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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culdoscope (And Accessories)
510(k) Number K051594
Device Name MCCARTNEY ACCESS TUBE
Applicant
Gynetech Pty. , Ltd.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact DENNIS HAHN
Correspondent
Gynetech Pty. , Ltd.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact DENNIS HAHN
Regulation Number884.1640
Classification Product Code
HEW  
Date Received06/16/2005
Decision Date 09/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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