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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 K860983
Device Name INTERPORE 200 POROUS HYDROXYAPATITE
Applicant
Interpore Intl.
18008 Skypark Cir.
Irvine,  CA  92714
Applicant Contact JO STEGWELL
Correspondent
Interpore Intl.
18008 Skypark Cir.
Irvine,  CA  92714
Correspondent Contact JO STEGWELL
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/17/1986
Decision Date 05/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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