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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 BV
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
Recalls CDRH Recalls
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