The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon Display Controller Part # 266-200-010.
Device ID | K884423 |
510k Number | K884423 |
Device Name: | HORIZON DISPLAY CONTROLLER PART # 266-200-010 |
Classification | Display, Cathode-ray Tube, Medical |
Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
Contact | Thomas W Connelly |
Correspondent | Thomas W Connelly MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
Product Code | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-19 |
Decision Date | 1989-05-31 |