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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K940265
Device Name PATTON LAPAROSCOPIC CATHETER INTRODUCER SET
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact DARCY JOB
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact DARCY JOB
Regulation Number884.1720
Classification Product Code
HET  
Date Received01/21/1994
Decision Date 09/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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