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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, fixation, ac-powered, ophthalmic
510(k) Number K933739
Device Name 360 DEGREE FIXATION LIGHT
Applicant
VARITRONICS
620 PKWY.
BROOMALL,  PA  19008
Applicant Contact WILFRED KLEIN
Correspondent
VARITRONICS
620 PKWY.
BROOMALL,  PA  19008
Correspondent Contact WILFRED KLEIN
Regulation Number886.1290
Classification Product Code
HPL  
Date Received08/03/1993
Decision Date 03/14/1994
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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