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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K862241
Device Name STANDARD BASIN KIT CUSTOM BASIN KIT
Applicant
Quali-Med, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Applicant Contact RICK FOSTER
Correspondent
Quali-Med, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Correspondent Contact RICK FOSTER
Regulation Number880.6850
Classification Product Code
FRG  
Date Received06/12/1986
Decision Date 08/01/1986
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
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