Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Pump, Infusion Or Syringe, Extra-Luminal
510(k) Number K931113
Device Name CADD-TPN(TM) AMBULATORY INFUSION SYSTEM
Applicant
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact W NUMAINVILLE
Correspondent
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact W NUMAINVILLE
Regulation Number876.5820
Classification Product Code
FIH  
Date Received03/04/1993
Decision Date 04/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-