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.
| Device ID | K955049 |
| 510k Number | K955049 |
| Device Name: | OLYMPUS FG-45/46-1 GRASPING FORCEPS |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Subhash Patel |
| Correspondent | Subhash Patel 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 | 1995-11-06 |
| Decision Date | 1995-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170152860 | K955049 | 000 |