The following data is part of a premarket notification filed by Medical Design Concepts, Inc. with the FDA for Operating Room Tray.
Device ID | K860160 |
510k Number | K860160 |
Device Name: | OPERATING ROOM TRAY |
Classification | Tray, Surgical, Instrument |
Applicant | MEDICAL DESIGN CONCEPTS, INC. 5741 PALMER WAY Carlsbad, CA 92008 |
Contact | Ronald Bertanzi |
Correspondent | Ronald Bertanzi MEDICAL DESIGN CONCEPTS, INC. 5741 PALMER WAY Carlsbad, CA 92008 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-16 |
Decision Date | 1986-02-27 |