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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 K141686
Device Name EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
Applicant
Smith Medical Asd, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact JIM JOHNSON
Correspondent
Smith Medical Asd, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact JIM JOHNSON
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/23/2014
Decision Date 10/28/2014
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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