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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K041344
Device Name OPEN BORE SYRINGE
Applicant
Isotis NV
Prof. Bronkhorstlaan 10-D
P.O. Box 98,3723 Ab
Bilthoven,  NL 3723MB
Applicant Contact ELIANE SCHUTTE
Correspondent
Isotis NV
Prof. Bronkhorstlaan 10-D
P.O. Box 98,3723 Ab
Bilthoven,  NL 3723MB
Correspondent Contact ELIANE SCHUTTE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/20/2004
Decision Date 07/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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