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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K061425
FOIA Releasable 510(k) K061425
Device Name PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01
Applicant
CAMBRIDGE ENDOSCOPIC DEVICES
261 CEDAR HILL STREET
QUALITY AND REGULATORY AFFAIRS
MARLBOROUGH,  MA  01752
Applicant Contact LYNN BOUGIE
Correspondent
CAMBRIDGE ENDOSCOPIC DEVICES
261 CEDAR HILL STREET
QUALITY AND REGULATORY AFFAIRS
MARLBOROUGH,  MA  01752
Correspondent Contact LYNN BOUGIE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/23/2006
Decision Date 08/10/2006
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
Recalls CDRH Recalls
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