The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for Set, Administration Intravascular.
Device ID | K874467 |
510k Number | K874467 |
Device Name: | SET, ADMINISTRATION INTRAVASCULAR |
Classification | Set, Administration, Intravascular |
Applicant | KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
Contact | Joyce Williams |
Correspondent | Joyce Williams KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-02 |
Decision Date | 1988-01-06 |