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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K010702
Device Name XUB EXTERNAL ULTRASOUND
Applicant
Kmi Kolster Methods, Inc.
1170 N. Gilbert St.
Anaheim,  CA  92801
Applicant Contact ALWIN H KOLSTER
Correspondent
Kmi Kolster Methods, Inc.
1170 N. Gilbert St.
Anaheim,  CA  92801
Correspondent Contact ALWIN H KOLSTER
Regulation Number890.5300
Classification Product Code
IMI  
Date Received03/08/2001
Decision Date 08/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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