Ansell / SLAM Condom Nippon / Device Mfg Billy Boy MAPA condoms GmbH / Ultra Inc. / MAPA GmbH / /
Event
FDA Phase / /
IndustryTerm
natural rubber latex / announcements concerning your device / basic technology / manufacturing practice requirements / marketed predicate devices / latex rubber / natural rubber latex sheath / manufacturing practice / silicon oil / qu ality systems / /
Organization
Division of Postmarket Surveillance / Food and Drug Administration / office of Compliance / Center for Devices and Radiological LHealth / office of Device Evaluation / Division of Reproductive / office of Surveillance / New Hampshire Avenue Document Mail Center / FDA / DEPARTMENT OF HEALTH / Reproductive / Gastro-Renal and Urological Devices Office / Center for Devices / /
Person
Job / Silver Spring / Billy Boy / P. Lerner / Frank / / /
Position
Director of Quality Management Date Prepared / /
Product
Federal Food / /
ProgrammingLanguage
Latex / /
ProvinceOrState
Maryland / /
Technology
radiation / 0002 N4APA Grbl-I c/o Mr. Mark A. Job Responsible Third Party Regulatory Technology / same basic technology / /
A[removed]Poo i/ 510(k) Summary JUN