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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 K964377
Device Name THERMAL REGULATION SYSTEM BLANKET
Applicant
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Applicant Contact ELAINE M HEAZELTINE
Correspondent
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Correspondent Contact ELAINE M HEAZELTINE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received11/01/1996
Decision Date 04/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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