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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 K890566
Device Name BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES
Applicant
Medi-Source, Inc.
50 Gordon Dr.
P.O. Box 874
Syosset,  NY  11791
Applicant Contact ANDREW GALAMBOS
Correspondent
Medi-Source, Inc.
50 Gordon Dr.
P.O. Box 874
Syosset,  NY  11791
Correspondent Contact ANDREW GALAMBOS
Regulation Number868.5110
Classification Product Code
CAE  
Date Received02/06/1989
Decision Date 03/15/1989
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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