FDA 510(k) K955650, OLYMPUS SD SERIES SNARES, by Olympus America, Inc.
FDA 510(k) K955650, OLYMPUS SD SERIES SNARES, by Olympus America, Inc.
| 510(k) Number | K955650 |
| Device Classification Name | Snare, Flexible |
| Device Name | OLYMPUS SD SERIES SNARES |
| Applicant | Olympus America, Inc. Two Corporate Center Dr. Melville, NY 11747 |
| Regulation Number | 876.43 |
| Classification Product Code | FDI |
| Date Received | 12/12/1995 |
| Decision Date | 03/29/1996 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Gastroenterology/Urology |
| 510k Review Panel | Gastroenterology/Urology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 130 |
| Redacted Pages | 33 |
| Unredacted Pages | 97 |
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