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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name airway, oropharyngeal, anesthesiology
510(k) Number K922748
Device Name GUEDEL AIRWAY
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 Number868.5110
Classification Product Code
CAE  
Date Received06/08/1992
Decision Date 07/10/1992
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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