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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K042145
Device Name READY-HEAT BLANKET
Applicant
TECHTRADE LLC
11900 GAINSBOROUGH ROAD
P.O.BOX 2005
POTOMAC,  MD  20854 -3305
Applicant Contact ARTHUR M HOROWITZ
Correspondent
TECHTRADE LLC
11900 GAINSBOROUGH ROAD
P.O.BOX 2005
POTOMAC,  MD  20854 -3305
Correspondent Contact ARTHUR M HOROWITZ
Regulation Number880.6060
Classification Product Code
KME  
Subsequent Product Code
IMD  
Date Received08/09/2004
Decision Date 09/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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