The following data is part of a premarket notification filed by Medivision Scope Service Center, Inc. with the FDA for Medivision Sinoscope.
Device ID | K971995 |
510k Number | K971995 |
Device Name: | MEDIVISION SINOSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
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 | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-30 |
Decision Date | 1997-06-26 |