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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headgear, Extraoral, Orthodontic
510(k) Number K982088
Device Name AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
Applicant
ORTHO KINETICS CORP.
1611A SOUTH MELROSE DRIVE,
SUITE 16
VISTA,  CA  92083
Applicant Contact STEVEN O LUSE
Correspondent
ORTHO KINETICS CORP.
1611A SOUTH MELROSE DRIVE,
SUITE 16
VISTA,  CA  92083
Correspondent Contact STEVEN O LUSE
Regulation Number872.5500
Classification Product Code
DZB  
Date Received06/15/1998
Decision Date 09/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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