The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Fg Series Of Rat Tooth Grasping Forceps (urology).
| Device ID | K962474 |
| 510k Number | K962474 |
| Device Name: | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) |
| Classification | Cystourethroscope |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-25 |
| Decision Date | 1996-12-20 |
| Summary: | summary |