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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 K011210
Device Name THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
Applicant
RUSCH INTL.
50 PLANTATION DR.
JAFFERY,  NH  03452
Applicant Contact JULIE A BEAUMONT
Correspondent
RUSCH INTL.
50 PLANTATION DR.
JAFFERY,  NH  03452
Correspondent Contact JULIE A BEAUMONT
Regulation Number868.5800
Classification Product Code
JOH  
Date Received04/19/2001
Decision Date 08/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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