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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Formalin, Neutral Buffered
510(k) Number K884755
Device Name CONSED FECAL CONCENTRATION SYSTEM
Applicant
Donald L. Price, Ph.D.
P.O. Box 10275
Bradenton,  FL  34282
Applicant Contact PRICE, PHD
Correspondent
Donald L. Price, Ph.D.
P.O. Box 10275
Bradenton,  FL  34282
Correspondent Contact PRICE, PHD
Regulation Number864.4010
Classification Product Code
IFP  
Date Received11/14/1988
Decision Date 01/10/1989
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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