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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 K871114
Device Name INSTANT HEAT COMPRESS, CHEMICAL TYPE
Applicant
Lexington Industries
465 # Perry St.
Johnstown,  NY  12095
Applicant Contact BRIAN L SMITH
Correspondent
Lexington Industries
465 # Perry St.
Johnstown,  NY  12095
Correspondent Contact BRIAN L SMITH
Regulation Number890.5710
Classification Product Code
IMD  
Date Received03/19/1987
Decision Date 03/25/1987
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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