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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, visual field, laser
510(k) Number K813429
Device Name LASER PHOTOCOAGULATOR ARGON MED. LASER
Applicant
AMERICAN LASER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN LASER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1360
Classification Product Code
HPJ  
Date Received12/08/1981
Decision Date 01/22/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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