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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 K955326
Device Name SPORTS CONTRAST THERAPY SYSTEM ST 7000
Applicant
Burke Neutech, Inc.
1765 Commerce Ave. N.,
St. Petersburg,  FL  33716
Applicant Contact ROBERT E BURKE
Correspondent
Burke Neutech, Inc.
1765 Commerce Ave. N.,
St. Petersburg,  FL  33716
Correspondent Contact ROBERT E BURKE
Regulation Number890.5720
Classification Product Code
ILO  
Date Received11/20/1995
Decision Date 04/10/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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