The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Resectoscope Sheath.
| Device ID | K931994 |
| 510k Number | K931994 |
| Device Name: | RESECTOSCOPE SHEATH |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-23 |
| Decision Date | 1994-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761021012 | K931994 | 000 |
| 04042761020893 | K931994 | 000 |
| 04042761021067 | K931994 | 000 |