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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, suturing, disposable
510(k) Number K863595
Device Name COATED SUTURE NEEDLE
Applicant
SHARPOINT, INC.
2850 WINDMILL RD.
READING,  PA  19608
Applicant Contact DAVID A YATES
Correspondent
SHARPOINT, INC.
2850 WINDMILL RD.
READING,  PA  19608
Correspondent Contact DAVID A YATES
Regulation Number878.4800
Classification Product Code
GAB  
Date Received09/15/1986
Decision Date 10/24/1986
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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