The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Overdose Kit.
Device ID | K770238 |
510k Number | K770238 |
Device Name: | OVERDOSE KIT |
Classification | Syringe, Piston |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-02-07 |
Decision Date | 1977-04-05 |