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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Orthodontic
510(k) Number K852975
Device Name INTERPORE 200 POROUS HYDROXYAPATITE
Applicant
INRTERPORE INTL.
P.O. BOX 19369
IRVINE,  CA  92713
Applicant Contact JO STEGWELL
Correspondent
INRTERPORE INTL.
P.O. BOX 19369
IRVINE,  CA  92713
Correspondent Contact JO STEGWELL
Regulation Number872.5410
Classification Product Code
DZC  
Date Received07/15/1985
Decision Date 10/31/1985
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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