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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 K972298
Device Name ETB TELESCOPE W/WORKING CHANNEL FOR SEPS
Applicant
The Altomec Corp.
400 Crenshaw Blvd., Suite 109
Torrance,  CA  90503
Applicant Contact GLENN A DUNKI-JACOBS
Correspondent
The Altomec Corp.
400 Crenshaw Blvd., Suite 109
Torrance,  CA  90503
Correspondent Contact GLENN A DUNKI-JACOBS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/19/1997
Decision Date 01/30/1998
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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