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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 K032339
Device Name CARDIOVATIONS PORTABLE VIDEO SYSTEM
Applicant
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Applicant Contact PETER CECCHINI
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/29/2003
Decision Date 08/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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