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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 K911257
Device Name MR-5200 FULL DISCLOSURE SYSTEM
Applicant
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Applicant Contact RICHARD WHITEHEAD
Correspondent
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Correspondent Contact RICHARD WHITEHEAD
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/21/1991
Decision Date 08/19/1991
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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