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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 DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact GRAHAM LUKEY
Correspondent
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
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
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