The following data is part of a premarket notification filed by Cormed, Inc., Sub. C.r.bard, Inc. with the FDA for Cormed Ii Ambulatory Infusion Pump.
Device ID | K850674 |
510k Number | K850674 |
Device Name: | CORMED II AMBULATORY INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | CORMED, INC., SUB. C.R.BARD, INC. 591 MAHAR ST. Medina, NY 14103 |
Contact | Thurman S Jess |
Correspondent | Thurman S Jess CORMED, INC., SUB. C.R.BARD, INC. 591 MAHAR ST. Medina, NY 14103 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-20 |
Decision Date | 1985-04-09 |