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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solvent, adhesive tape
510(k) Number K881359
Device Name DECALCIFYING SOLUTION II
Applicant
STEPHENS SCIENTIFIC
7 ASTRO PL., PO BOX 1116
DENVILLE,  NJ  07834
Applicant Contact JAMES D YEAKEL
Correspondent
STEPHENS SCIENTIFIC
7 ASTRO PL., PO BOX 1116
DENVILLE,  NJ  07834
Correspondent Contact JAMES D YEAKEL
Regulation Number878.4730
Classification Product Code
KOX  
Date Received03/31/1988
Decision Date 04/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
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