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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Feeding
510(k) Number K100099
FOIA Releasable 510(k) K100099
Device Name ORAL/ENTERAL SYRINGES
Applicant
Philips Children'S Medical Ventures
191 Wyngate Dr.
Monroeville,  PA  15146
Applicant Contact LISA CASAVANT
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.5980
Classification Product Code
FPD  
Date Received01/13/2010
Decision Date 06/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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