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Food law / Pharmaceuticals policy / Orthopedic surgery / Plastic surgery / Tissue expansion / Medical device / Premarket approval / Center for Devices and Radiological Health / Federal Food / Drug / and Cosmetic Act / Medicine / Food and Drug Administration / Health


Microsoft Word - Revised 510(k) Summary-Removed Text Boxes (FDA Request[removed])
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Document Date: 2014-11-12 09:20:26

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File Size: 1,05 MB

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City

FROOHFWLRQ / RWKHU DVSHFW / Victor / WKLV FROOHFWLRQ / /

Company

K140383 Trade / Regulatory Affairs 1123 North U.S. / Specialty Surgical Products Incorporated / Regulatory Affairs Specialty Surgical Products Inc. / /

Country

United States / /

Currency

USD / /

/

Event

FDA Phase / /

Facility

North U.S. Highway / The port / New Hampshire Avenue Document Control Center / /

/

IndustryTerm

announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Surgical Devices Office / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / F.A.C.S. Director Division / CDRH’s office of Surveillance / Device Evaluation Center for Devices and Radiological Health / /

Person

SHU UHVSRQVH LQFOXGLQJ / Sherry Null / Silver Spring / David Krause / Binita S. Ashar / /

/

Position

Vice President / /

Product

Federal Food / /

ProvinceOrState

Montana / Maryland / /

Region

North U.S. / /

Technology

radiation / /

URL

http /

SocialTag