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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 K041841
Device Name PACHYCAM
Applicant
Oculus Optikgerate GmbH
Munchholzhauser Strasse 29
Wetzla-Dutenhofen,  DE D-35582
Applicant Contact JOERG IWANCZUK
Correspondent
Oculus Optikgerate GmbH
Munchholzhauser Strasse 29
Wetzla-Dutenhofen,  DE D-35582
Correspondent Contact JOERG IWANCZUK
Regulation Number886.1850
Classification Product Code
MXK  
Date Received07/08/2004
Decision Date 01/28/2005
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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