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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 K955564
Device Name RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
Applicant
RUSCH, INC.
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact NEIL R ARMSTRONG
Correspondent
RUSCH, INC.
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact NEIL R ARMSTRONG
Regulation Number868.5800
Classification Product Code
JOH  
Date Received12/06/1995
Decision Date 06/28/1996
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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