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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen, Low Concentration, Venturi
510(k) Number K951652
Device Name VENTIMASK MK IV
Applicant
Flexicare Medical, Ltd.
East Quay, Bridgwater
Somerset,  GB TA64DB
Applicant Contact COLIN BECKETT
Correspondent
Flexicare Medical, Ltd.
East Quay, Bridgwater
Somerset,  GB TA64DB
Correspondent Contact COLIN BECKETT
Regulation Number868.5600
Classification Product Code
BYF  
Date Received04/10/1995
Decision Date 04/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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