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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 K911195
Device Name DUNLAP HEAT PAD
Applicant
Home Healthcare Products, Inc.
C/O Ntl Associates, Inc.
29 Ainsworth Ave.
East Brunswick,  NJ  08816
Applicant Contact ERIC FLAM
Correspondent
Home Healthcare Products, Inc.
C/O Ntl Associates, Inc.
29 Ainsworth Ave.
East Brunswick,  NJ  08816
Correspondent Contact ERIC FLAM
Regulation Number890.5740
Classification Product Code
IRT  
Date Received03/18/1991
Decision Date 08/12/1991
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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