The following data is part of a premarket notification filed by Gamp & Assoc. with the FDA for Gamp & Assoc. Disposable Endoocular Laser Probe.
| Device ID | K954307 |
| 510k Number | K954307 |
| Device Name: | GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE |
| Classification | Photocoagulator And Accessories |
| Applicant | GAMP & ASSOC. 15 FOXHUNT DR. Chesterfield, MO 63017 |
| Contact | James Taylor |
| Correspondent | James Taylor GAMP & ASSOC. 15 FOXHUNT DR. Chesterfield, MO 63017 |
| Product Code | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-15 |
| Decision Date | 1995-12-22 |