The following data is part of a premarket notification filed by Gamp & Assoc. with the FDA for Gamp & Associates Disposable Bare End Fiber.
| Device ID | K952580 |
| 510k Number | K952580 |
| Device Name: | GAMP & ASSOCIATES DISPOSABLE BARE END FIBER |
| Classification | Endoilluminator |
| Applicant | GAMP & ASSOC. 3237 HAAS Bridgeton, MO 63044 |
| Contact | James Taylor |
| Correspondent | James Taylor GAMP & ASSOC. 3237 HAAS Bridgeton, MO 63044 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-05 |
| Decision Date | 1995-09-01 |