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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aligner, sequential
510(k) Number K981095
Device Name ALIGN SYSTEM
Applicant
ALIGN TECHNOLOGY
18140 SMOKESIGNAL DR.
SAN DIEGO,  CA  92127
Applicant Contact CAROL PATTERSON
Correspondent
ALIGN TECHNOLOGY
18140 SMOKESIGNAL DR.
SAN DIEGO,  CA  92127
Correspondent Contact CAROL PATTERSON
Regulation Number872.5470
Classification Product Code
NXC  
Date Received03/26/1998
Decision Date 09/08/1998
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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