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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K141097
Device Name CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE
Applicant
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD.
21A SCIENCE PLAZA, INTRENATIONAL SCIENCE PARK NO.1355
JINJIHU AVENUE
SUZHOU, JIANGSU,  CN 215021
Applicant Contact JO QIAO
Correspondent
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD.
21A SCIENCE PLAZA, INTRENATIONAL SCIENCE PARK NO.1355
JINJIHU AVENUE
SUZHOU, JIANGSU,  CN 215021
Correspondent Contact JO QIAO
Regulation Number878.4750
Classification Product Code
GDW  
Date Received04/28/2014
Decision Date 09/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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