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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K962074
Device Name VM PLUS PEAK FLOWMETER
Applicant
Clement Clarke Intl., Ltd.
Edinburgh Way
Harlow,  GB CM20 2TT
Applicant Contact MICHAEL J WILKINSON
Correspondent
Clement Clarke Intl., Ltd.
Edinburgh Way
Harlow,  GB CM20 2TT
Correspondent Contact MICHAEL J WILKINSON
Regulation Number868.1860
Classification Product Code
BZH  
Date Received05/28/1996
Decision Date 01/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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