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 |