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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 K040632
Device Name SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
Applicant
SMITHS MEDICAL ASD, INC.
160 WEYMOUTH ST.
ROCKLAND,  MA  02370
Applicant Contact VERNON TRIMBLE
Correspondent
SMITHS MEDICAL ASD, INC.
160 WEYMOUTH ST.
ROCKLAND,  MA  02370
Correspondent Contact VERNON TRIMBLE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received03/10/2004
Decision Date 04/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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