The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Mcgaw/epic I.v. Admin. Set.
Device ID | K800403 |
510k Number | K800403 |
Device Name: | MCGAW/EPIC I.V. ADMIN. SET |
Classification | Set, Administration, Intravascular |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-26 |
Decision Date | 1980-04-16 |