The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Fg-45/46-1 Grasping Forceps(urology).
| Device ID | K962387 |
| 510k Number | K962387 |
| Device Name: | OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| 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 | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-20 |
| Decision Date | 1996-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170031721 | K962387 | 000 |
| 14953170031707 | K962387 | 000 |
| 14953170031677 | K962387 | 000 |
| 14953170031653 | K962387 | 000 |