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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixative, Alcohol Containing
510(k) Number K862725
Device Name SACCOMANNO SPECIMAN SOLUTION
Applicant
Mill-Rose Laboratory
7310 Corporate Blvd.
Mentor,  OH  44060 -4885
Applicant Contact MARK KOZAK
Correspondent
Mill-Rose Laboratory
7310 Corporate Blvd.
Mentor,  OH  44060 -4885
Correspondent Contact MARK KOZAK
Regulation Number864.4010
Classification Product Code
LDZ  
Date Received07/17/1986
Decision Date 08/01/1986
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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