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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K880241
Device Name 'HILT-WAY' RESUSCITATOR
Applicant
MEDIFIELD LTD.
6, TAVERNERS SQUARE
SILVER ROAD, NORWICH
ENGLAND,  GB NR3 4SY
Applicant Contact RICHARD GILL
Correspondent
MEDIFIELD LTD.
6, TAVERNERS SQUARE
SILVER ROAD, NORWICH
ENGLAND,  GB NR3 4SY
Correspondent Contact RICHARD GILL
Regulation Number868.5110
Classification Product Code
CAE  
Date Received01/20/1988
Decision Date 03/31/1988
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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