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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, absorbable, (scleral buckling methods)
510(k) Number K875014
Device Name LABTICIAN RETINAL IMPLANTS
Applicant
LABTICIAN PRODUCTS, INC.
7701 HOLIDAY DR.
SARASOTA,  FL  34231 -5313
Applicant Contact DAVID SCULATI
Correspondent
LABTICIAN PRODUCTS, INC.
7701 HOLIDAY DR.
SARASOTA,  FL  34231 -5313
Correspondent Contact DAVID SCULATI
Regulation Number886.3300
Classification Product Code
HQJ  
Date Received12/04/1987
Decision Date 02/26/1988
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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