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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 K963887
Device Name PT-PAC PORTABLE HEATING PAD
Applicant
Anthony A. Chiurco
2761 Trenton Rd.
Levitown Road,  PA  19056
Applicant Contact LAWRENCE E LIBERTI
Correspondent
Anthony A. Chiurco
2761 Trenton Rd.
Levitown Road,  PA  19056
Correspondent Contact LAWRENCE E LIBERTI
Regulation Number890.5740
Classification Product Code
IRT  
Date Received09/26/1996
Decision Date 03/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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