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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, surgical instrument, disposable
510(k) Number K850325
Device Name STERILE SUTURE REMOVAL KIT
Applicant
EXCEL HEALTH CARE PRODUCTS
5001 HADLEY RD.
SOUTH PLAINFIELD,  NJ  07080
Applicant Contact DAVID CATLIN
Correspondent
EXCEL HEALTH CARE PRODUCTS
5001 HADLEY RD.
SOUTH PLAINFIELD,  NJ  07080
Correspondent Contact DAVID CATLIN
Regulation Number878.4800
Classification Product Code
KDD  
Date Received01/28/1985
Decision Date 02/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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