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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K943276
Device Name WARMTOUCH PLASTIC WARMING COVER
Applicant
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Applicant Contact JEFFREY W BIGGERS
Correspondent
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Correspondent Contact JEFFREY W BIGGERS
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received07/07/1994
Decision Date 09/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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