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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 K980617
Device Name MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
Applicant
UROHEALTH SYSTEMS, INC.
8850 M-89
RICHLAND,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
UROHEALTH SYSTEMS, INC.
8850 M-89
RICHLAND,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number878.4750
Classification Product Code
GDW  
Date Received01/23/1998
Decision Date 04/09/1998
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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