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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 K791659
Device Name MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL
Applicant
COBURN OPTICAL IND., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COBURN OPTICAL IND., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/22/1979
Decision Date 10/11/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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