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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 K071023
Device Name REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C
Applicant
Reach Surgical, Inc.
4480 Lake Forest Dr., Suite 414
Cincinnati,  OH  45242
Applicant Contact RICH GRANT
Correspondent
Reach Surgical, Inc.
4480 Lake Forest Dr., Suite 414
Cincinnati,  OH  45242
Correspondent Contact RICH GRANT
Regulation Number878.4750
Classification Product Code
GDW  
Date Received04/11/2007
Decision Date 08/28/2008
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
Predetermined Change
Control Plan Authorized		 No
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