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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K981091
Device Name NEOCOLLOID, ORTHOPRINT
Applicant
Zhermack S.P.A.
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact EVAN DICK
Correspondent
Zhermack S.P.A.
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact EVAN DICK
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/25/1998
Decision Date 05/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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