The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Cadd-tpn Model 5700 Ambulatory Infusion System.
Device ID | K902374 |
510k Number | K902374 |
Device Name: | CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM |
Classification | Pump, Infusion |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | Edward Numainville |
Correspondent | Edward Numainville 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 | 1990-05-30 |
Decision Date | 1990-09-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00610586017073 | K902374 | 000 |