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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 K980436
Device Name CLASS III REVERSE PULL FACEMASK
Applicant
Ortho Kinetics Corp.
1611a S. Melrose Dr.
Suite 16
Vista,  CA  92083
Applicant Contact STEVEN O LUSE
Correspondent
Ortho Kinetics Corp.
1611a S. Melrose Dr.
Suite 16
Vista,  CA  92083
Correspondent Contact STEVEN O LUSE
Regulation Number872.5500
Classification Product Code
DZB  
Date Received02/04/1998
Decision Date 04/27/1998
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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