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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 K881394
Device Name NON-STERILE SUTURE NEEDLES
Applicant
CHINA NATIONAL MEDICINES C/O HAVEL'S
3726 LONSDALE AVE.
CINCINNATI,  OH  45227
Applicant Contact JOHN ROGERS
Correspondent
CHINA NATIONAL MEDICINES C/O HAVEL'S
3726 LONSDALE AVE.
CINCINNATI,  OH  45227
Correspondent Contact JOHN ROGERS
Regulation Number878.4800
Classification Product Code
GDL  
Date Received04/04/1988
Decision Date 04/08/1988
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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