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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stylet, tracheal tube
510(k) Number K910659
Device Name AUGUSTINE STYLET
Applicant
AUGUSTINE MEDICAL, INC.
10393 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Applicant Contact SCOTT D AUGUSTINE
Correspondent
AUGUSTINE MEDICAL, INC.
10393 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Correspondent Contact SCOTT D AUGUSTINE
Regulation Number868.5790
Classification Product Code
BSR  
Date Received02/14/1991
Decision Date 05/17/1991
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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