The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Otv-s5 Oes Video System.
| Device ID | K955404 |
| 510k Number | K955404 |
| Device Name: | OTV-S5 OES VIDEO SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-27 |
| Decision Date | 1996-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170323584 | K955404 | 000 |
| 04953170028465 | K955404 | 000 |
| 04953170028311 | K955404 | 000 |
| 04953170028304 | K955404 | 000 |
| 04953170026706 | K955404 | 000 |
| 04953170026690 | K955404 | 000 |
| 04953170026294 | K955404 | 000 |
| 04953170023972 | K955404 | 000 |
| 04953170023910 | K955404 | 000 |
| 04953170023828 | K955404 | 000 |
| 04953170023804 | K955404 | 000 |
| 04953170023729 | K955404 | 000 |
| 04953170023422 | K955404 | 000 |
| 04953170023392 | K955404 | 000 |
| 04953170141836 | K955404 | 000 |
| 04953170141805 | K955404 | 000 |
| 04953170141744 | K955404 | 000 |
| 04953170059148 | K955404 | 000 |
| 04953170136894 | K955404 | 000 |
| 04953170136917 | K955404 | 000 |
| 04953170252945 | K955404 | 000 |
| 04953170252914 | K955404 | 000 |
| 04953170228865 | K955404 | 000 |
| 04953170228834 | K955404 | 000 |
| 04953170179822 | K955404 | 000 |
| 04953170142246 | K955404 | 000 |
| 04953170142222 | K955404 | 000 |
| 04953170142215 | K955404 | 000 |
| 04953170141898 | K955404 | 000 |
| 04953170141867 | K955404 | 000 |
| 04953170141775 | K955404 | 000 |
| 04953170141676 | K955404 | 000 |
| 04953170141645 | K955404 | 000 |
| 04953170141614 | K955404 | 000 |
| 04953170141584 | K955404 | 000 |
| 04953170136931 | K955404 | 000 |
| 04953170024054 | K955404 | 000 |