The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Cadd-micro(tm) Model 5900 Ambulatory Infusion Pump.
Device ID | K931132 |
510k Number | K931132 |
Device Name: | CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | David H Short |
Correspondent | David H Short PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-05 |
Decision Date | 1993-08-20 |