The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Instrument And Accessory Kit.
Device ID | K780488 |
510k Number | K780488 |
Device Name: | INSTRUMENT AND ACCESSORY KIT |
Classification | Kit, Surgical Instrument, Disposable |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-27 |
Decision Date | 1978-04-12 |