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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 K940160
Device Name TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
Applicant
Burke Neutech, Inc.
11701 S. Belcher Rd.,
Suite 119
Largo,  FL  34643
Applicant Contact ROBERT E BURKE
Correspondent
Burke Neutech, Inc.
11701 S. Belcher Rd.,
Suite 119
Largo,  FL  34643
Correspondent Contact ROBERT E BURKE
Regulation Number890.5720
Classification Product Code
ILO  
Date Received01/12/1994
Decision Date 05/27/1994
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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