The following data is part of a premarket notification filed by Medivision Scope Service Center, Inc. with the FDA for Medivision Arthroscop.
Device ID | K971996 |
510k Number | K971996 |
Device Name: | MEDIVISION ARTHROSCOP |
Classification | Arthroscope |
Applicant | MEDIVISION SCOPE SERVICE CENTER, INC. 1440 S. STATE COLLEGE BLVD. #1D Anaheim, CA 92806 |
Contact | Wayne B Sterner |
Correspondent | Wayne B Sterner MEDIVISION SCOPE SERVICE CENTER, INC. 1440 S. STATE COLLEGE BLVD. #1D Anaheim, CA 92806 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-30 |
Decision Date | 1997-07-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304400887 | K971996 | 000 |
10886705026241 | K971996 | 000 |
10886705026234 | K971996 | 000 |
10886705026227 | K971996 | 000 |
10886705026210 | K971996 | 000 |