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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Albumin-Based
510(k) Number K881477
Device Name HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED
Applicant
Stat Path
P.O. Box 6
Riderwood,  MD  21139 -0006
Applicant Contact R BOSTWICK
Correspondent
Stat Path
P.O. Box 6
Riderwood,  MD  21139 -0006
Correspondent Contact R BOSTWICK
Regulation Number864.4010
Classification Product Code
KEL  
Date Received04/07/1988
Decision Date 04/18/1988
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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