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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
Predetermined Change
Control Plan Authorized		 No
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