The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Bipolar Forceps.
| Device ID | K955623 |
| 510k Number | K955623 |
| Device Name: | OLYMPUS BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-11 |
| Decision Date | 1996-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761001106 | K955623 | 000 |