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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 K123056
Device Name PASCAL LASER INDIRECT OPHTHALMOSCOPE
Applicant
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS)
2800 PLEASANT HILL RD
SUITE 175
PLEASANT HILL,  CA  94523
Applicant Contact PAMELA M BUCKMAN
Correspondent
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS)
2800 PLEASANT HILL RD
SUITE 175
PLEASANT HILL,  CA  94523
Correspondent Contact PAMELA M BUCKMAN
Regulation Number886.4390
Classification Product Code
HQF  
Date Received10/01/2012
Decision Date 11/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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