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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
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