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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 K110951
Device Name 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
Applicant
ALCON RESEARCH, LTD.
15800 ALTON PARKWAY
IRVINE,  CA  92618
Applicant Contact MARTIN A KAUFMAN
Correspondent
ALCON RESEARCH, LTD.
15800 ALTON PARKWAY
IRVINE,  CA  92618
Correspondent Contact MARTIN A KAUFMAN
Regulation Number886.4690
Classification Product Code
HQB  
Subsequent Product Codes
HMX   HQE   NGY  
Date Received04/04/2011
Decision Date 10/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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