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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 K972842
Device Name INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
Applicant
INTERPORE INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Applicant Contact DAVID P BALDING
Correspondent
INTERPORE INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Correspondent Contact DAVID P BALDING
Regulation Number872.3930
Classification Product Code
LYC  
Date Received08/01/1997
Decision Date 10/30/1997
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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