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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 K884897
Device Name FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
Applicant
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Applicant Contact THOMAS W CONNELLY
Correspondent
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Correspondent Contact THOMAS W CONNELLY
Regulation Number870.2810
Classification Product Code
DSF  
Date Received11/23/1988
Decision Date 03/09/1989
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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