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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 K894716
Device Name DIRECTABLE COAXIAL CATHETER SET
Applicant
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/25/1989
Decision Date 08/23/1989
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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