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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collagen Corneal Shield
510(k) Number K862315
Device Name FYODOROV COLLAGEN CORNEAL SHIELD
Applicant
Medical Technology Development Corp.
11300 49th St. N.
Clearwater,  FL  33520
Applicant Contact JOSE H BEDOYA
Correspondent
Medical Technology Development Corp.
11300 49th St. N.
Clearwater,  FL  33520
Correspondent Contact JOSE H BEDOYA
Regulation Number886.4750
Classification Product Code
MOE  
Date Received06/18/1986
Decision Date 01/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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