The following data is part of a premarket notification filed by Trend Medical, Inc. with the FDA for Patientmate Tm.
Device ID | K854754 |
510k Number | K854754 |
Device Name: | PATIENTMATE TM |
Classification | Set, Administration, Intravascular |
Applicant | TREND MEDICAL, INC. 2941 S. MAIN, SUITE B Santa Ana, CA 92707 |
Contact | Bruce S Daniels |
Correspondent | Bruce S Daniels TREND MEDICAL, INC. 2941 S. MAIN, SUITE B Santa Ana, CA 92707 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-27 |
Decision Date | 1986-02-04 |