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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, ac-powered
510(k) Number K923742
Device Name TOPOGRAPHIC SCANNING SYSTEM TOPSS
Applicant
CARLZEISS MEDITEC INC.
10467 ROSELLE ST.
SAN DIEGO,  CA  92121
Applicant Contact ANDREAS W DREHER
Correspondent
CARLZEISS MEDITEC INC.
10467 ROSELLE ST.
SAN DIEGO,  CA  92121
Correspondent Contact ANDREAS W DREHER
Regulation Number886.1570
Classification Product Code
HLI  
Date Received07/27/1992
Decision Date 03/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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