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 |