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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 K902180
Device Name TRACHEAL TUBE STYLET
Applicant
Sims Surgical, Inc.
15 Kit St.
P.O. Box 724
Keene,  NH  03431
Applicant Contact JOHN D FORSTER
Correspondent
Sims Surgical, Inc.
15 Kit St.
P.O. Box 724
Keene,  NH  03431
Correspondent Contact JOHN D FORSTER
Regulation Number868.5790
Classification Product Code
BSR  
Date Received05/15/1990
Decision Date 07/19/1990
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
Recalls CDRH Recalls
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