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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 K020604
Device Name WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
Applicant
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588 -2719
Applicant Contact GINA TO
Correspondent
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588 -2719
Correspondent Contact GINA TO
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received02/25/2002
Decision Date 04/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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