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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Synthetic, Intraoral
510(k) Number K990363
Device Name BIOMESH BIODEGRADABLE GTR BARRIER
Applicant
SAMYANG CORP.
200 GREGORY LANE, SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
SAMYANG CORP.
200 GREGORY LANE, SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number872.3930
Classification Product Code
NPK  
Date Received02/05/1999
Decision Date 04/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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