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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 K936133
Device Name PERCUTANEOUS TRACHEOSTOMY KIT
Applicant
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5800
Classification Product Code
JOH  
Date Received12/23/1993
Decision Date 03/23/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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