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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 K101378
Device Name FRANKENMAN SURGICAL STAPLERS
Applicant
SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD.
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Applicant Contact JEAN ASQUITH
Correspondent
SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD.
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Correspondent Contact JEAN ASQUITH
Regulation Number878.4750
Classification Product Code
GDW  
Date Received05/17/2010
Decision Date 06/29/2010
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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