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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution, Decalcifier, Acid Containing
510(k) Number K872625
Device Name DECALCIFYING SOLUTION
Applicant
Stephens Scientific
7 Astro Pl., P.O. Box 1116
Denville,  NJ  07834
Applicant Contact JAMES D YEAKEL
Correspondent
Stephens Scientific
7 Astro Pl., P.O. Box 1116
Denville,  NJ  07834
Correspondent Contact JAMES D YEAKEL
Regulation Number864.4010
Classification Product Code
KDX  
Date Received07/06/1987
Decision Date 08/06/1987
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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