The following data is part of a premarket notification filed by Cp Medical with the FDA for Injection Cap.
Device ID | K913337 |
510k Number | K913337 |
Device Name: | INJECTION CAP |
Classification | Set, Administration, Intravascular |
Applicant | CP MEDICAL P.O. BOX 5668 Huntington Beach, CA 92615 |
Contact | Carl Grodach |
Correspondent | Carl Grodach CP MEDICAL P.O. BOX 5668 Huntington Beach, CA 92615 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-26 |
Decision Date | 1992-02-11 |