The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Prisma Dispos. Brite Lite Fiberoptic Endoillumina..
| Device ID | K875005 |
| 510k Number | K875005 |
| Device Name: | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield, MO 63017 |
| Contact | Todd J Hessel |
| Correspondent | Todd J Hessel ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield, MO 63017 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-04 |
| Decision Date | 1988-03-14 |