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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 K875122
Device Name DISPOSABLE STERILE SYRINGE FILTERS
Applicant
Corning Medical & Scientific
275 River St.
Oneonta,  NY  13820
Applicant Contact BARBARA L MULLIN
Correspondent
Corning Medical & Scientific
275 River St.
Oneonta,  NY  13820
Correspondent Contact BARBARA L MULLIN
Regulation Number864.3010
Classification Product Code
KET  
Date Received12/15/1987
Decision Date 01/12/1988
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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