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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 K894922
Device Name WR3500 AND WR3600 SERIES RECORDERS
Applicant
Western Graphtec
11 Vanderbilt St.
Irvine,  CA  92618 -2067
Applicant Contact JIM CRAIG
Correspondent
Western Graphtec
11 Vanderbilt St.
Irvine,  CA  92618 -2067
Correspondent Contact JIM CRAIG
Regulation Number870.2810
Classification Product Code
DSF  
Date Received08/02/1989
Decision Date 01/26/1990
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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