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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 K091211
Device Name EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS
Applicant
ETHICON ENDO-SUGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Applicant Contact ASIFA VONHOF
Correspondent
ETHICON ENDO-SUGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Correspondent Contact ASIFA VONHOF
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/27/2009
Decision Date 09/04/2009
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
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