The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Oes Laparo-thoraco Videoscope (rigid).
| Device ID | K955456 |
| 510k Number | K955456 |
| Device Name: | OES LAPARO-THORACO VIDEOSCOPE (RIGID) |
| Classification | Laparoscope, Gynecologic (and 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-29 |
| Decision Date | 1996-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761066815 | K955456 | 000 |
| 04042761066709 | K955456 | 000 |
| 04042761066501 | K955456 | 000 |