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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K934669
Device Name ARC
Applicant
MEDELEC LTD.
MANOR WAY
OLD WOKING
SURREY, ENGLAND GU22 9JU,  GB
Applicant Contact J B HOLLOWAY
Correspondent
MEDELEC LTD.
MANOR WAY
OLD WOKING
SURREY, ENGLAND GU22 9JU,  GB
Correspondent Contact J B HOLLOWAY
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/29/1993
Decision Date 04/26/1994
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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