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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K001025
Device Name LIFECARD CF COMPACT RECORDER
Applicant
Reynolds Medical , Ltd.
377 Rt. 17 S
Hasbrouck,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Reynolds Medical , Ltd.
377 Rt. 17 S
Hasbrouck,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/30/2000
Decision Date 04/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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