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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K072814
Device Name CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
Applicant
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact ROBERT ZOTT
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact ROBERT ZOTT
Regulation Number878.4800
Classification Product Code
KDD  
Date Received10/01/2007
Decision Date 04/16/2008
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
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