The following data is part of a premarket notification filed by American Mcgaw with the FDA for Mixing Container.
Device ID | K843954 |
510k Number | K843954 |
Device Name: | MIXING CONTAINER |
Classification | Container, I.v. |
Applicant | AMERICAN MCGAW P.O. BOX 1187 Santa Ana, CA 92711 |
Contact | Floyd Benjamin |
Correspondent | Floyd Benjamin AMERICAN MCGAW P.O. BOX 1187 Santa Ana, CA 92711 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-09 |
Decision Date | 1984-11-28 |