The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for 14 Color Video Display 211-260-010.
Device ID | K893585 |
510k Number | K893585 |
Device Name: | 14 COLOR VIDEO DISPLAY 211-260-010 |
Classification | System, Image Processing, Radiological |
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 | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-09 |
Decision Date | 1989-07-20 |