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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 K914383
Device Name LIFE-AIR 1000 PATIENT WARMING COVERS
Applicant
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Applicant Contact DAVID DYKEHOUSE
Correspondent
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Correspondent Contact DAVID DYKEHOUSE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received10/01/1991
Decision Date 03/30/1992
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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