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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 K921742
Device Name OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
Applicant
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707
Applicant Contact GRAHAM LUKEY
Correspondent
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact GRAHAM LUKEY
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/13/1992
Decision Date 05/26/1993
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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