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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 K111108
Device Name PASCAL STREAMLINE 577 (WITH ACCESSORIES)
Applicant
TOPCON MEDICAL LASER SYSTEMS, INC
3130 CORONADO DRIVE
SANTA CLARA,  CA  95054
Applicant Contact JOHN JOSSY
Correspondent
TOPCON MEDICAL LASER SYSTEMS, INC
3130 CORONADO DRIVE
SANTA CLARA,  CA  95054
Correspondent Contact JOHN JOSSY
Regulation Number886.4390
Classification Product Code
HQF  
Date Received04/20/2011
Decision Date 08/11/2011
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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