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 K991203
Device Name IRRIGATION OR INFUSION PUMP K PUMP
Applicant
Kmi Kolster Methods, Inc.
2550 W. Rowland Ave.
Anaheim,  CA  92804
Applicant Contact ALWIN H KOLSTER
Correspondent
Kmi Kolster Methods, Inc.
2550 W. Rowland Ave.
Anaheim,  CA  92804
Correspondent Contact ALWIN H KOLSTER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/08/1999
Decision Date 10/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-