The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Intervascular Adminstration Set.
Device ID | K911753 |
510k Number | K911753 |
Device Name: | INTERVASCULAR ADMINSTRATION SET |
Classification | Set, Administration, Intravascular |
Applicant | MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 -9791 |
Contact | John G D'angelo |
Correspondent | John G D'angelo MCGAW, INC. 2525 MCGAW AVE. P.O. BOX 19791 Irvine, CA 92713 -9791 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-18 |
Decision Date | 1991-06-24 |