The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Resectoscope Sheath.
| Device ID | K931995 |
| 510k Number | K931995 |
| Device Name: | RESECTOSCOPE SHEATH |
| Classification | Resectoscope |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Barry Sands |
| Correspondent | Barry Sands OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FJL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-23 |
| Decision Date | 1993-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761004190 | K931995 | 000 |
| 04042761004176 | K931995 | 000 |
| 04042761001823 | K931995 | 000 |