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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 K061513
Device Name LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
Applicant
Smiths Medical Asd, Inc.
10 Bowman Dr.
Keene,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
Smiths Medical Asd, Inc.
10 Bowman Dr.
Keene,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/01/2006
Decision Date 08/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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