The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Contain Implant.
| Device ID | K091120 |
| 510k Number | K091120 |
| Device Name: | MEDPOR CONTAIN IMPLANT |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Contact | Jerri L Mann |
| Correspondent | Jerri L Mann POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-17 |
| Decision Date | 2010-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252084495 | K091120 | 000 |
| 07613252084488 | K091120 | 000 |
| 07613252084471 | K091120 | 000 |
| 07613252084464 | K091120 | 000 |
| 07613252084457 | K091120 | 000 |
| 07613252084440 | K091120 | 000 |
| 07613252084433 | K091120 | 000 |
| 07613252084426 | K091120 | 000 |
| 07613252084419 | K091120 | 000 |