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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 K884126
Device Name E-RAM
Applicant
Reynolds Medical , Ltd.
6490 Excelsior Blvd.
E-109
Minneapolis,  MN  55426
Applicant Contact TERRY SUBY
Correspondent
Reynolds Medical , Ltd.
6490 Excelsior Blvd.
E-109
Minneapolis,  MN  55426
Correspondent Contact TERRY SUBY
Regulation Number870.2800
Classification Product Code
DSH  
Date Received09/30/1988
Decision Date 10/30/1989
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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