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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 K990894
Device Name ETB TROCAR SYSTEM
Applicant
The Altomec Corp.
400 Crenshaw Blvd., Suite 109
Torrance,  CA  90503
Applicant Contact JIM CHITTY
Correspondent
The Altomec Corp.
400 Crenshaw Blvd., Suite 109
Torrance,  CA  90503
Correspondent Contact JIM CHITTY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/18/1999
Decision Date 05/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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