The following data is part of a premarket notification filed by Iop, Inc. with the FDA for Surgisis Ocular Graft.
| Device ID | K053622 |
| 510k Number | K053622 |
| Device Name: | SURGISIS OCULAR GRAFT |
| Classification | Prosthesis, Eyelid Spacer/graft, Biologic |
| Applicant | IOP, INC. 3184 AIRWAY AVE., BLDG. B Costa Mesa, CA 92626 |
| Contact | Jason Malecka |
| Correspondent | Jason Malecka IOP, INC. 3184 AIRWAY AVE., BLDG. B Costa Mesa, CA 92626 |
| Product Code | NXM |
| CFR Regulation Number | 886.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-28 |
| Decision Date | 2006-03-15 |
| Summary: | summary |