The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Utensil & Procedure Trays.
Device ID | K810242 |
510k Number | K810242 |
Device Name: | UTENSIL & PROCEDURE TRAYS |
Classification | Fiber, Medical, Absorbent |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRL |
CFR Regulation Number | 880.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-28 |
Decision Date | 1981-04-15 |