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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 K944447
Device Name COOL/HEAT THERAPY APPLICATOR
Applicant
Medical Science Technology, Inc.
1810 Stafford Ave.
Fredericksburg,  VA  22401
Applicant Contact STUART HORN
Correspondent
Medical Science Technology, Inc.
1810 Stafford Ave.
Fredericksburg,  VA  22401
Correspondent Contact STUART HORN
Regulation Number890.5720
Classification Product Code
ILO  
Date Received09/12/1994
Decision Date 02/09/1995
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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