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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K042706
Device Name OSSATURA DENTAL
Applicant
ISOTIS ORTHOBIOLOGICS, INC
2 GOODYEAR, SUITE B
IRVINE,  CA  92618
Applicant Contact PAUL DONER
Correspondent
ISOTIS ORTHOBIOLOGICS, INC
2 GOODYEAR, SUITE B
IRVINE,  CA  92618
Correspondent Contact PAUL DONER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received09/30/2004
Decision Date 10/20/2004
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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