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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 K090821
Device Name CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L
Applicant
FRANKENMAN INTERNATIONAL LIMITED
1705 S. CAPITAL OF HWY
SUITE 500
AUSTIN,  TX  78746
Applicant Contact JEAN ASQUITH
Correspondent
FRANKENMAN INTERNATIONAL LIMITED
1705 S. CAPITAL OF HWY
SUITE 500
AUSTIN,  TX  78746
Correspondent Contact JEAN ASQUITH
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/26/2009
Decision Date 06/10/2009
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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