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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 K003277
Device Name SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
Applicant
POWERMED, INC.
4 B EAST BRIDGE ST.
NEW HOPE,  PA  18938
Applicant Contact MICHELE LUCEY
Correspondent
POWERMED, INC.
4 B EAST BRIDGE ST.
NEW HOPE,  PA  18938
Correspondent Contact MICHELE LUCEY
Regulation Number878.4750
Classification Product Code
GDW  
Date Received10/19/2000
Decision Date 12/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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