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 |