The following data is part of a premarket notification filed by Medivision Scope Service Center, Inc. with the FDA for Medivision Laparoscope.
| Device ID | K984434 |
| 510k Number | K984434 |
| Device Name: | MEDIVISION LAPAROSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-14 |
| Decision Date | 1999-03-17 |