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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K913026
Device Name TTU-100THERMAL THERAPY UNIT
Applicant
Danninger Medical Technology, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Applicant Contact DAVID W.SCHLERF
Correspondent
Danninger Medical Technology, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Correspondent Contact DAVID W.SCHLERF
Regulation Number890.5720
Classification Product Code
ILO  
Date Received07/09/1991
Decision Date 12/13/1991
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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