The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Mr-5200 Full Disclosure System.
| Device ID | K911257 |
| 510k Number | K911257 |
| Device Name: | MR-5200 FULL DISCLOSURE SYSTEM |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Richard Whitehead |
| Correspondent | Richard Whitehead MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-21 |
| Decision Date | 1991-08-19 |