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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, endoscopic
510(k) Number K022989
Device Name RADLITE TISSUE RETRACTOR SYSTEM
Applicant
GENZYME BIOSURGERY
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Applicant Contact KAREN K SYLVIA
Correspondent
GENZYME BIOSURGERY
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Correspondent Contact KAREN K SYLVIA
Regulation Number878.4580
Classification Product Code
FSW  
Date Received09/09/2002
Decision Date 11/25/2002
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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