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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K082196
Device Name STATIC VESSEL ANALYZER
Applicant
Imedos GmbH
317 Shore Breeze Ln.
League City,  TX  77573
Applicant Contact HANS STROMEYER
Correspondent
Imedos GmbH
317 Shore Breeze Ln.
League City,  TX  77573
Correspondent Contact HANS STROMEYER
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Codes
NFF   NFG  
Date Received08/04/2008
Decision Date 06/16/2009
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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