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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filters, Cell Collection, Tissue Processing
510(k) Number K844671
Device Name CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON
Applicant
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Applicant Contact WILLIAM J PLGNATO
Correspondent
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Correspondent Contact WILLIAM J PLGNATO
Regulation Number864.3010
Classification Product Code
KET  
Date Received11/30/1984
Decision Date 02/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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