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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 K831078
Device Name STRAITH ORAL AIRWAY
Applicant
SURGICAL TECHNOLOGY LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SURGICAL TECHNOLOGY LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5110
Classification Product Code
CAE  
Date Received04/04/1983
Decision Date 06/24/1983
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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