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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Heating, Powered
510(k) Number K962038
Device Name PES HOT/COLD COMPRESS
Applicant
Princeton Electronic Systems, Inc.
37 Station Dr.
Princeton Jct,  NJ  08550
Applicant Contact CHARLES H SEIDEL, JR.
Correspondent
Princeton Electronic Systems, Inc.
37 Station Dr.
Princeton Jct,  NJ  08550
Correspondent Contact CHARLES H SEIDEL, JR.
Regulation Number890.5740
Classification Product Code
IRT  
Date Received05/24/1996
Decision Date 11/13/1996
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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