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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name barrier, animal source, intraoral
510(k) Number K140518
Device Name GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
Applicant
GEISTLICH PHARMA AG
555 twelfth Street, NW
Washington,  DC  20004
Applicant Contact DANIEL A KRACOV
Correspondent
GEISTLICH PHARMA AG
555 twelfth Street, NW
Washington,  DC  20004
Correspondent Contact DANIEL A KRACOV
Regulation Number872.3930
Classification Product Code
NPL  
Date Received02/28/2014
Decision Date 07/18/2014
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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