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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 K093624
FOIA Releasable 510(k) K093624
Device Name OPTISCAN MODEL OPTISCAN CEIS
Applicant
Optiscan Pty. , Ltd.
15-17 Normanby Rd.
Notting Hill Vic,  AU 3168
Applicant Contact PETER PAVLICEK
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/23/2009
Decision Date 03/05/2010
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
Predetermined Change
Control Plan Authorized		 No
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