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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 K863207
Device Name OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
Applicant
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707 -7550
Applicant Contact MICHAEL HANUSHEWSKY
Correspondent
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707 -7550
Correspondent Contact MICHAEL HANUSHEWSKY
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/19/1986
Decision Date 10/30/1986
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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