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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K870451
Device Name SKIN GRAFT PRESERVATION MEDIUM (TISSUE)
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
Regulation Number864.2220
Classification Product Code
KIT  
Date Received02/03/1987
Decision Date 05/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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