The following data is part of a premarket notification filed by Lifemed Of California with the FDA for Intravascular Iv Set, Iv Set With Burette, Extension Set.
Device ID | K001329 |
510k Number | K001329 |
Device Name: | INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET |
Classification | Set, Administration, Intravascular |
Applicant | LIFEMED OF CALIFORNIA 1216 SOUTH ALLEC ST. Anaheim, CA 92805 -6301 |
Contact | Patricia Brinker |
Correspondent | Patricia Brinker LIFEMED OF CALIFORNIA 1216 SOUTH ALLEC ST. Anaheim, CA 92805 -6301 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-27 |
Decision Date | 2001-02-14 |