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 |