The following data is part of a premarket notification filed by Medivision Scope Service Center, Inc. with the FDA for Medivision Hysteroscope.
| Device ID | K982659 |
| 510k Number | K982659 |
| Device Name: | MEDIVISION HYSTEROSCOPE |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-30 |
| Decision Date | 1998-10-07 |