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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 K911097
Device Name PR4
Applicant
Mortara Instrument, Inc.
181 Cedar Hill Rd.
Marlboro,  MA  01752
Applicant Contact RODNEY CAMBRE
Correspondent
Mortara Instrument, Inc.
181 Cedar Hill Rd.
Marlboro,  MA  01752
Correspondent Contact RODNEY CAMBRE
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/12/1991
Decision Date 08/07/1991
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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