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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Paper Chart
510(k) Number K901385
Device Name GABRIEL MEDICAL CLS THERMAL RECORDER
Applicant
Gabriel Medical, Inc.
18662 Mac Authur, Suite 200
Irvine,  CA  92715
Applicant Contact HARRY GABRIEL
Correspondent
Gabriel Medical, Inc.
18662 Mac Authur, Suite 200
Irvine,  CA  92715
Correspondent Contact HARRY GABRIEL
Regulation Number870.2810
Classification Product Code
DSF  
Date Received03/26/1990
Decision Date 05/09/1990
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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