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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 K960971
Device Name OCULIGHT GL
Applicant
IRIDERM DIV.
340 PIONEER WAY
MOUNTAIN VIEW,  CA  94041 -1506
Applicant Contact THEODORE A BOUTACOFF
Correspondent
IRIDERM DIV.
340 PIONEER WAY
MOUNTAIN VIEW,  CA  94041 -1506
Correspondent Contact THEODORE A BOUTACOFF
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received03/11/1996
Decision Date 08/28/1996
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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