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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name speculum, vaginal, nonmetal
510(k) Number K021017
Device Name LEESPEC DISPOSABLE VAGINAL SPECULUM
Applicant
ITL CORPORATION, PTY LTD.
41-45 TENNANT ST.
FYSHWICK, CANBERRA ACT,  AU 2609
Applicant Contact WILLIAM L MOBBS
Correspondent
ITL CORPORATION, PTY LTD.
41-45 TENNANT ST.
FYSHWICK, CANBERRA ACT,  AU 2609
Correspondent Contact WILLIAM L MOBBS
Regulation Number884.4530
Classification Product Code
HIB  
Date Received03/29/2002
Decision Date 06/19/2002
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
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