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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Umbilical Artery
510(k) Number K942827
Device Name SENTRY INSERTION TRAY
Applicant
Sentry Medical Products, Inc.
331 S. Eisenhower Ln.
Lombard,  IL  60148
Applicant Contact JAMES G STOKES
Correspondent
Sentry Medical Products, Inc.
331 S. Eisenhower Ln.
Lombard,  IL  60148
Correspondent Contact JAMES G STOKES
Regulation Number880.5200
Classification Product Code
FOS  
Date Received06/14/1994
Decision Date 11/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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