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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 K935797
Device Name SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE
Applicant
STEBAR INSTRUMENT CORP.
3066 THREE MILE RD/ M/W/
GRAND RAPIDS,  MI  49504
Applicant Contact STEVEN M DAUGHERTY
Correspondent
STEBAR INSTRUMENT CORP.
3066 THREE MILE RD/ M/W/
GRAND RAPIDS,  MI  49504
Correspondent Contact STEVEN M DAUGHERTY
Regulation Number868.5790
Classification Product Code
BSR  
Date Received12/02/1993
Decision Date 01/12/1994
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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