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 Warmer, Irrigation Solution
510(k) Number K002859
Device Name SSW-STERILE SOLUTION WARMER
Applicant
Kmi Kolster Methods, Inc.
708 N. Valley, Suite N
Anaheim,  CA  92801
Applicant Contact ALWIN H KOLSTER
Correspondent
Kmi Kolster Methods, Inc.
708 N. Valley, Suite N
Anaheim,  CA  92801
Correspondent Contact ALWIN H KOLSTER
Regulation Number890.5950
Classification Product Code
LHC  
Date Received09/13/2000
Decision Date 11/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-