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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 K090159
Device Name INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES
Applicant
INCISIVE SURGICAL, INC.
14405 21ST AVE N.
SUITE 130
PLYMOUTH,  MN  55447
Applicant Contact JAMES PETERSON
Correspondent
INCISIVE SURGICAL, INC.
14405 21ST AVE N.
SUITE 130
PLYMOUTH,  MN  55447
Correspondent Contact JAMES PETERSON
Regulation Number878.4750
Classification Product Code
GDW  
Date Received01/22/2009
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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