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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Corneal Storage
510(k) Number K870249
Device Name MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM
Applicant
Bioclinical Laboratory Services, Inc.
9310 Hunting Valley Rd.
Clarence,  NY  14031
Applicant Contact FIKE, PHD
Correspondent
Bioclinical Laboratory Services, Inc.
9310 Hunting Valley Rd.
Clarence,  NY  14031
Correspondent Contact FIKE, PHD
Classification Product Code
LYX  
Date Received01/21/1987
Decision Date 04/06/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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