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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement Obturator
510(k) Number K010840
Device Name SYNPLUG
Applicant
Isotis NV
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J M. NOLTE
Correspondent
Isotis NV
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J M. NOLTE
Regulation Number878.3300
Classification Product Code
LZN  
Date Received03/21/2001
Decision Date 04/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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