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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 St., NW
Washington,  DC  20004
Applicant Contact DANIEL A KRACOV
Correspondent
Geistlich Pharma AG
555 Twelfth St., 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
Predetermined Change
Control Plan Authorized		 No
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