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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 K950165
Device Name INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS
Applicant
INTERPORE INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Applicant Contact WILLIAM A FRANKLIN
Correspondent
INTERPORE INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Correspondent Contact WILLIAM A FRANKLIN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/17/1995
Decision Date 03/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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