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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Cast
510(k) Number K903946
Device Name COOL CAST(R)
Applicant
HAWTHORNE PRODUCTS, INC.
BOX 66, R.D. #2
DUNKIRK,  IN  47336
Applicant Contact DON R HOBSON
Correspondent
HAWTHORNE PRODUCTS, INC.
BOX 66, R.D. #2
DUNKIRK,  IN  47336
Correspondent Contact DON R HOBSON
Regulation Number888.5940
Classification Product Code
LGF  
Date Received08/27/1990
Decision Date 12/31/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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