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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, Disposable
510(k) Number K953542
Device Name COLDGEL
Applicant
PRISM TECHNOLOGIES, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSETIN
Correspondent
PRISM TECHNOLOGIES, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSETIN
Regulation Number890.5710
Classification Product Code
IMD  
Subsequent Product Code
HHD  
Date Received07/28/1995
Decision Date 10/30/1995
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
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