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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, endosseous, root-form
510(k) Number K122198
Device Name 6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM
Applicant
OCO BIOMEDICAL
9550 SAN MATEO BLVD
NE, SUITE -C
ALBUQUERQUE,  NM  87113
Applicant Contact JACK BLOOM
Correspondent
OCO BIOMEDICAL
9550 SAN MATEO BLVD
NE, SUITE -C
ALBUQUERQUE,  NM  87113
Correspondent Contact JACK BLOOM
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/24/2012
Decision Date 04/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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