The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Ocular Screw & Accessories.
| Device ID | K954939 |
| 510k Number | K954939 |
| Device Name: | MEDPOR OCULAR SCREW & ACCESSORIES |
| Classification | Implant, Eye Sphere |
| Applicant | POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park, GA 30349 -2417 |
| Contact | Howard A Mercer |
| Correspondent | Howard A Mercer POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park, GA 30349 -2417 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-30 |
| Decision Date | 1996-01-25 |