The following data is part of a premarket notification filed by Circon Video with the FDA for Adult Resectoscope.
Device ID | K890328 |
510k Number | K890328 |
Device Name: | ADULT RESECTOSCOPE |
Classification | Hysteroscope (and Accessories) |
Applicant | CIRCON VIDEO 300 STILLWATER AVE. P.O. BOX BOX 1971 Stanford, CT 06904 -1971 |
Contact | Taylor, Pe |
Correspondent | Taylor, Pe CIRCON VIDEO 300 STILLWATER AVE. P.O. BOX BOX 1971 Stanford, CT 06904 -1971 |
Product Code | HIH |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-23 |
Decision Date | 1990-02-06 |