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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tenaculum, Uterine
510(k) Number K073182
Device Name GYN DISPOSABLES TENACULUM 356T
Applicant
Gyn-Disposables, Inc.
2671 Appling Rd.
Memphis,  TN  38133
Applicant Contact JAMES K PATTERSON
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number884.4530
Classification Product Code
HDC  
Date Received11/13/2007
Decision Date 11/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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