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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K902790
Device Name NAPA
Applicant
G-ORTHO LAB
1441 KAPIOLANI BLVD.
SUITE 520
HONOLULU,  HI  96814
Applicant Contact PETER GEORGE
Correspondent
G-ORTHO LAB
1441 KAPIOLANI BLVD.
SUITE 520
HONOLULU,  HI  96814
Correspondent Contact PETER GEORGE
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received06/26/1990
Decision Date 09/19/1990
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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