The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Safeline System Turn Lock Cannula.
Device ID | K941244 |
510k Number | K941244 |
Device Name: | SAFELINE SYSTEM TURN LOCK CANNULA |
Classification | Set, Administration, Intravascular |
Applicant | MCGAW, INC. 2525 MCGAW AVE. Irvine, CA 92714 -5895 |
Contact | John G D'angelo |
Correspondent | John G D'angelo MCGAW, INC. 2525 MCGAW AVE. Irvine, CA 92714 -5895 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-15 |
Decision Date | 1994-11-29 |