Summary Cook Incorporated / Karl Storz Endoscopy - America Inc. / Cook Incorporated / GCJ (Laparoscope general and plastic surgery) Cook Incorporated / K120468 Trade / RAC Cook Incorporated / /
Continent
America / /
Event
FDA Phase / / /
IndustryTerm
announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address htp/wwfayvMdcleie/estrefro/nutvdfuthm Sincerely / /
Organization
MalvinaB.Rdla Director Division of Ophthalmic / Neurological and Ear / Division of Postmarket Surveillance / Food and Drug Administration / office of Compliance / office of Device Evaluation / Center for Devi~es and Radiological Health / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Device Evaluation Center for Devices and Radiological Health Enclosure / Ear / Nose and Throat Devices Office / /
Person
Karl Storz / Susanne Galin / / /
Position
N~age Nitinol Stone Extractor / NGage Nitinol Stone Extractor / Tipless Stone Extractor / NGage Nitinol Stone Extractor / Intended Use The NCircle Nitinol Tipless Stone Extractor / Technological Characteristics The NCircle Nitinol Tipless Stone Extractor / NCircle Nitinol Tipless Stone Extractor NGage Nitinol Stone Extractor / NCircle Tipless Stone Extractor / NCfrcle Nitinol Tipless Stone Extractor / NCircle Nitinol Tipless Stone Extractor / NCircle Nitinol Tipless Stone Extractor / NGage Nitinol Stone Extractor / NCircle Nitinol Tipless Stone Extractor and the NGage Nitinol Stone Extractor / Device Description The NCircle Nitinol Tipless Stone Extractor and NGage Nitinol Stone Extractor / Premarket Notification NCircle Nitinol Tipless Stone Extractor / NGage Nitinol Stone Extractor / Premnarket Notification NCircle Nitinol Tipless Stone Extractor / NGage Nitinol Stone Extractor / Regulatory Affairs Specialist / NCircle Nitinol Tipless Stone Extractor and NGage Nitinol Stone Extractor / /
Cook Incorporated Traditional 5 10(k) Premarket Notification NCircle Nitinol Tipless Stone Extractor, NGage Nitinol Stone Extractor 15 February[removed]