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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 K925630
Device Name ELASTOPLAST HEAT PLASTER
Applicant
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Applicant Contact KENNETH M NICOLL
Correspondent
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Correspondent Contact KENNETH M NICOLL
Regulation Number890.5740
Classification Product Code
IRT  
Date Received11/06/1992
Decision Date 02/25/1994
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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