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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K121187
Device Name KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
Applicant
KATALYST SURGICAL, LLC
1331 H ST NW, 12TH FL
WASHINGTON,  DC  20005
Applicant Contact MICHELLE MCDONOUGH
Correspondent
KATALYST SURGICAL, LLC
1331 H ST NW, 12TH FL
WASHINGTON,  DC  20005
Correspondent Contact MICHELLE MCDONOUGH
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Codes
HQB   MPA  
Date Received04/19/2012
Decision Date 09/17/2012
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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