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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, reusable
510(k) Number K813589
Device Name SHARTPOINT EYED NEEDLES
Applicant
S. JACKSON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
S. JACKSON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GDL  
Date Received12/28/1981
Decision Date 01/18/1982
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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