The following data is part of a premarket notification filed by Porex Technologies Corp. with the FDA for Medpor Surg Implant Material:prefor Cran/fac Impla.
| Device ID | K922489 |
| 510k Number | K922489 |
| Device Name: | MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA |
| Classification | Prosthesis, Chin, Internal |
| Applicant | POREX TECHNOLOGIES CORP. 500 BOHANNON RD. Fairburn, GA 30213 |
| Contact | Howard A Mercer |
| Correspondent | Howard A Mercer POREX TECHNOLOGIES CORP. 500 BOHANNON RD. Fairburn, GA 30213 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-27 |
| Decision Date | 1992-09-02 |