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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K934749
Device Name FREEWAY LITE NEBULIZER COMPRESSOR
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 Number868.5630
Classification Product Code
CAF  
Date Received10/04/1993
Decision Date 07/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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