The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Safeline I.v. Bag Access Device.
Device ID | K955594 |
510k Number | K955594 |
Device Name: | SAFELINE I.V. BAG ACCESS DEVICE |
Classification | Set, I.v. Fluid Transfer |
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 | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-08 |
Decision Date | 1996-03-06 |
Summary: | summary |