The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Ocular Conformer.
| Device ID | K972034 |
| 510k Number | K972034 |
| Device Name: | MEDPOR OCULAR CONFORMER |
| Classification | Conformer, Ophthalmic |
| Applicant | POREX SURGICAL, INC. 500 BOHANNON RD. Fairburn, GA 30213 |
| Contact | Howard Mercer |
| Correspondent | Howard Mercer POREX SURGICAL, INC. 500 BOHANNON RD. Fairburn, GA 30213 |
| Product Code | HQN |
| CFR Regulation Number | 886.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1998-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252086376 | K972034 | 000 |
| 07613252085584 | K972034 | 000 |
| 07613252085577 | K972034 | 000 |
| 07613252085560 | K972034 | 000 |
| 07613252085553 | K972034 | 000 |
| 07613252085546 | K972034 | 000 |
| 07613252085539 | K972034 | 000 |
| 07613252085522 | K972034 | 000 |
| 07613252085515 | K972034 | 000 |
| 07613252085508 | K972034 | 000 |
| 07613252085492 | K972034 | 000 |
| 07613252085591 | K972034 | 000 |
| 07613252085607 | K972034 | 000 |
| 07613252086369 | K972034 | 000 |
| 07613252086352 | K972034 | 000 |
| 07613252086246 | K972034 | 000 |
| 07613252086239 | K972034 | 000 |
| 07613252086222 | K972034 | 000 |
| 07613252085652 | K972034 | 000 |
| 07613252085645 | K972034 | 000 |
| 07613252085638 | K972034 | 000 |
| 07613252085621 | K972034 | 000 |
| 07613252085614 | K972034 | 000 |
| 07613252085485 | K972034 | 000 |