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
510(k) Number K863864
Device Name AMBULATORY INFUSION PUMP, MODEL AS30C
Applicant
Travenol Laboratories, S.A.
Londonderry Tpke.
Hooksett,  NH  03104
Applicant Contact ROGER A LEROUX
Correspondent
Travenol Laboratories, S.A.
Londonderry Tpke.
Hooksett,  NH  03104
Correspondent Contact ROGER A LEROUX
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/03/1986
Decision Date 02/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-