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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K031847
Device Name CARDIOVATIONS RETRACTOR
Applicant
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Applicant Contact PETER CECCHINI
Correspondent
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Correspondent Contact PETER CECCHINI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/16/2003
Decision Date 07/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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