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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
510(k) Number K940888
Device Name SYSTEM 22 PAEDIATRIC MASK
Applicant
MEDIC-AID LTD.
HOOK LANE, PAGHAM,
SUSSEX, U.K. PO21 3PP,  GB
Applicant Contact HOWARD BURNETT
Correspondent
MEDIC-AID LTD.
HOOK LANE, PAGHAM,
SUSSEX, U.K. PO21 3PP,  GB
Correspondent Contact HOWARD BURNETT
Regulation Number868.5580
Classification Product Code
BYG  
Date Received02/25/1994
Decision Date 04/19/1994
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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