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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 K970811
Device Name DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN
Applicant
PNEUMOCARE, INC.
23991 IRONHEAD LN.
LAGUNA NIGUEL,  CA  92677
Applicant Contact JOSEPH H BALES
Correspondent
PNEUMOCARE, INC.
23991 IRONHEAD LN.
LAGUNA NIGUEL,  CA  92677
Correspondent Contact JOSEPH H BALES
Regulation Number868.5800
Classification Product Code
JOH  
Date Received03/05/1997
Decision Date 11/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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