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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K952811
Device Name 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS
Applicant
IMPLANT INNOVATIONS, INC.
3071 CONTINENTAL DR.
WEST PALM BEACH,  FL  33407
Applicant Contact WILLIAM G CONETY
Correspondent
IMPLANT INNOVATIONS, INC.
3071 CONTINENTAL DR.
WEST PALM BEACH,  FL  33407
Correspondent Contact WILLIAM G CONETY
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/19/1995
Decision Date 08/30/1995
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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