The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Barrier Surgical Implant Biomaterial.
| Device ID | K952677 |
| 510k Number | K952677 |
| Device Name: | MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL |
| Classification | Prosthesis, Chin, Internal |
| Applicant | POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park, GA 30349 -2417 |
| Contact | Howard Mercer |
| Correspondent | Howard Mercer POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park, GA 30349 -2417 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-12 |
| Decision Date | 1995-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252729860 | K952677 | 000 |
| 07613252086093 | K952677 | 000 |
| 07613252086086 | K952677 | 000 |
| 07613252086048 | K952677 | 000 |
| 07613252085805 | K952677 | 000 |
| 07613252085799 | K952677 | 000 |
| 07613252084914 | K952677 | 000 |
| 07613252084907 | K952677 | 000 |
| 07613252084723 | K952677 | 000 |