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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 K933764
Device Name LIFE-AIR 1000 PATIENT WARMING COVER
Applicant
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Applicant Contact TOM PHLIPOT
Correspondent
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Correspondent Contact TOM PHLIPOT
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received07/22/1993
Decision Date 11/09/1993
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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