The following data is part of a premarket notification filed by River Medical, Inc. with the FDA for River Pump.
Device ID | K932895 |
510k Number | K932895 |
Device Name: | RIVER PUMP |
Classification | Pump, Infusion |
Applicant | RIVER MEDICAL, INC. 7737 KENAMAR CT. San Diego, CA 92121 |
Contact | Jim C Caputo |
Correspondent | Jim C Caputo RIVER MEDICAL, INC. 7737 KENAMAR CT. San Diego, CA 92121 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-14 |
Decision Date | 1994-03-31 |