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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K925893
Device Name OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT
Applicant
OEM MEDICAL DIV.
8741 LANDMARK RD.
P.O. BOX 27604
RICHMOND,  VA  23228
Applicant Contact JERRY W SCHEIB
Correspondent
OEM MEDICAL DIV.
8741 LANDMARK RD.
P.O. BOX 27604
RICHMOND,  VA  23228
Correspondent Contact JERRY W SCHEIB
Regulation Number868.5240
Classification Product Code
CAI  
Date Received11/17/1992
Decision Date 03/12/1993
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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