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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 St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSETIN
Correspondent
Prism Technologies, Inc.
555 Thirteenth St. NW
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
Predetermined Change
Control Plan Authorized		 No
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