The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Auxiliary Tray.
Device ID | K802088 |
510k Number | K802088 |
Device Name: | AUXILIARY TRAY |
Classification | Tray, Surgical, Instrument |
Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-02 |
Decision Date | 1980-11-28 |