The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Hf Resection Electrode, Loop W/runner Hyster/acces.
Device ID | K931764 |
510k Number | K931764 |
Device Name: | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES |
Classification | Hysteroscope (and Accessories) |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Barry E Sands |
Correspondent | Barry E 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 | 1993-04-08 |
Decision Date | 1994-06-08 |