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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 K981845
Device Name HAWK ANAESTHESIA INDUCTION UNIT
Applicant
Medical Industrial Equipment
Falcon Rd. Sowton Industrial
Estate
Exeter, Devon,  GB EX2 7NA
Applicant Contact HENRY MARSHALL
Correspondent
Medical Industrial Equipment
Falcon Rd. Sowton Industrial
Estate
Exeter, Devon,  GB EX2 7NA
Correspondent Contact HENRY MARSHALL
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received05/26/1998
Decision Date 11/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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