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 |