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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name burr, corneal, battery-powered
510(k) Number K960261
Device Name PALLIKARIS BRUSH
Applicant
ALCON LABORATORIES, INC.
520 N. SEMORAN BLVD.
SUITE 180
ORLANDO,  FL  32807
Applicant Contact S. K MCGARVEY
Correspondent
ALCON LABORATORIES, INC.
520 N. SEMORAN BLVD.
SUITE 180
ORLANDO,  FL  32807
Correspondent Contact S. K MCGARVEY
Regulation Number886.4070
Classification Product Code
HOG  
Date Received01/18/1996
Decision Date 03/11/1996
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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