The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Sd Series Snares.
| Device ID | K955650 |
| 510k Number | K955650 |
| Device Name: | OLYMPUS SD SERIES SNARES |
| Classification | Snare, Flexible |
| 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 | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-12 |
| Decision Date | 1996-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170328197 | K955650 | 000 |
| 14953170036146 | K955650 | 000 |
| 04953170036101 | K955650 | 000 |
| 14953170036030 | K955650 | 000 |
| 04953170035999 | K955650 | 000 |
| 14953170035965 | K955650 | 000 |
| 14953170035958 | K955650 | 000 |
| 04953170035920 | K955650 | 000 |
| 04953170035906 | K955650 | 000 |
| 04953170035869 | K955650 | 000 |
| 14953170035835 | K955650 | 000 |
| 04953170035739 | K955650 | 000 |
| 14953170035705 | K955650 | 000 |
| 14953170035644 | K955650 | 000 |
| 04953170035609 | K955650 | 000 |
| 14953170036207 | K955650 | 000 |
| 04953170036231 | K955650 | 000 |
| 14953170298469 | K955650 | 000 |
| 14953170298452 | K955650 | 000 |
| 14953170298445 | K955650 | 000 |
| 14953170244596 | K955650 | 000 |
| 14953170165983 | K955650 | 000 |
| 14953170142038 | K955650 | 000 |
| 04953170036880 | K955650 | 000 |
| 04953170036750 | K955650 | 000 |
| 14953170036726 | K955650 | 000 |
| 04953170036620 | K955650 | 000 |
| 04953170036491 | K955650 | 000 |
| 14953170036467 | K955650 | 000 |
| 04953170036361 | K955650 | 000 |
| 14953170036337 | K955650 | 000 |
| 04953170035562 | K955650 | 000 |