The following data is part of a premarket notification filed by Medivision Scope Service Center, Inc. with the FDA for Medivision Cystoscope.
Device ID | K982620 |
510k Number | K982620 |
Device Name: | MEDIVISION CYSTOSCOPE |
Classification | Cystoscope And Accessories, Flexible/rigid |
Applicant | MEDIVISION SCOPE SERVICE CENTER, INC. 1440 SOUTH STATE COLLEGE BLVD. SUITE 1C Anaheim, CA 92806 |
Contact | Wayne B Sterner |
Correspondent | Wayne B Sterner MEDIVISION SCOPE SERVICE CENTER, INC. 1440 SOUTH STATE COLLEGE BLVD. SUITE 1C Anaheim, CA 92806 |
Product Code | FAJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-27 |
Decision Date | 1998-09-30 |