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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K020219
Device Name RPI SKIN OR AIR TEMPERATURE PROBE
Applicant
Replacement Parts Industries, Inc.
P.O. Box 5019
Chatsworth,  CA  91313 -5019
Applicant Contact IRA LAPIDES
Correspondent
Replacement Parts Industries, Inc.
P.O. Box 5019
Chatsworth,  CA  91313 -5019
Correspondent Contact IRA LAPIDES
Regulation Number880.5130
Classification Product Code
FMT  
Date Received01/22/2002
Decision Date 04/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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