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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 K023918
Device Name RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
Applicant
RUSCH INTL.
50 PLANTATION DR.
JAFFERY,  NH  03452
Applicant Contact RICK LYKINS
Correspondent
RUSCH INTL.
50 PLANTATION DR.
JAFFERY,  NH  03452
Correspondent Contact RICK LYKINS
Regulation Number868.5800
Classification Product Code
JOH  
Date Received11/25/2002
Decision Date 03/28/2003
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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