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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 K900199
Device Name LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY
Applicant
LASAG AG
500 IOLAB DR.
CLAREMONT,  CA  91711
Applicant Contact SHELLEY BEADLE
Correspondent
LASAG AG
500 IOLAB DR.
CLAREMONT,  CA  91711
Correspondent Contact SHELLEY BEADLE
Regulation Number886.4390
Classification Product Code
HQF  
Date Received01/16/1990
Decision Date 03/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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