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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K030787
Device Name SHILEY FLEXTRA TRACHEOSTOMY TUBE
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Applicant Contact GINA TO
Correspondent
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Correspondent Contact GINA TO
Regulation Number868.5800
Classification Product Code
JOH  
Date Received03/12/2003
Decision Date 11/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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