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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 K101705
Device Name MISTRAL-AIR WARMING SYSTEM
Applicant
The Surgical Company International B.V.
3821 Ah Amersfoort
Beeldschermweg 6g,  NL
Applicant Contact ADRIAAN P INTVELD
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/17/2010
Decision Date 07/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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