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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K022168
Device Name ENVOY
Applicant
Mennen Medical , Ltd.
10123 Main St.
Clarence,  NY  14031
Applicant Contact DAVID P JOHNSON
Correspondent
Mennen Medical , Ltd.
10123 Main St.
Clarence,  NY  14031
Correspondent Contact DAVID P JOHNSON
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DSI  
Date Received07/03/2002
Decision Date 08/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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