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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photocoagulator And Accessories
510(k) Number K922735
Device Name ZIESS ENDOPROBE
Applicant
Carl Zeiss, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Applicant Contact CHRISTOPHER TALBOT
Correspondent
Carl Zeiss, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number886.4690
Classification Product Code
HQB  
Date Received06/08/1992
Decision Date 07/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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