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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Analysis, Anterior Segment
510(k) Number K984443
FOIA Releasable 510(k) K984443
Device Name ORBSCAN
Applicant
Technolas Perfect Vision GmbH
P.O. Box 17190
Anaheim,  CA  92817 -7190
Applicant Contact BETSY M JOHNSON
Correspondent
Technolas Perfect Vision GmbH
P.O. Box 17190
Anaheim,  CA  92817 -7190
Correspondent Contact BETSY M JOHNSON
Regulation Number886.1850
Classification Product Code
MXK  
Date Received12/14/1998
Decision Date 03/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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