The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Oes Laparo-thoraco Videoscope Type V.
| Device ID | K955403 |
| 510k Number | K955403 |
| Device Name: | OES LAPARO-THORACO VIDEOSCOPE TYPE V |
| 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 | 1995-11-27 |
| Decision Date | 1996-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170350597 | K955403 | 000 |
| 04953170340741 | K955403 | 000 |
| 04953170316159 | K955403 | 000 |