The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Primary Iv Set.
Device ID | K964435 |
510k Number | K964435 |
Device Name: | PRIMARY IV SET |
Classification | Stopcock, I.v. Set |
Applicant | ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
Contact | Richard Waters |
Correspondent | Richard Waters ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-05 |
Decision Date | 1997-04-02 |
Summary: | summary |