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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transilluminator, ac-powered
510(k) Number K934269
Device Name FIBEROPTIC ILLUMINATED INSTRUMENTS
Applicant
VISITEC CO.
7575 COMMERCE COURT
SARASOTA,  FL  34243 -3218
Applicant Contact DAVID A CLAPP
Correspondent
VISITEC CO.
7575 COMMERCE COURT
SARASOTA,  FL  34243 -3218
Correspondent Contact DAVID A CLAPP
Regulation Number886.1945
Classification Product Code
HJM  
Date Received08/31/1993
Decision Date 05/17/1994
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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