510(k) K022665 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
| Applicant | Hohenstein Enterprises, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 9, 2002 |
| Received | Aug 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022665
No recall in the FDA data names this 510(k).
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