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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 K962193
Device Name PORTLAND TROCARS
Applicant
SURGICAL INNOVATIONS PLC
1070 THORNWOOD LN.
DACULA,  GA  30211 -3007
Applicant Contact MICHAEL A CLARK
Correspondent
SURGICAL INNOVATIONS PLC
1070 THORNWOOD LN.
DACULA,  GA  30211 -3007
Correspondent Contact MICHAEL A CLARK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/07/1996
Decision Date 08/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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