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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 K912836
Device Name CANNULA AND TROCAR
Applicant
Oceanside Biomedics
2379 Industry St.
Oceanside,  CA  92054
Applicant Contact LOUIE POLONI
Correspondent
Oceanside Biomedics
2379 Industry St.
Oceanside,  CA  92054
Correspondent Contact LOUIE POLONI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/26/1991
Decision Date 08/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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