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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 K060129
Device Name IGS VAGINAL SPECULUM
Applicant
Innovative Gynecological Solutions, LLC
5 Wentworth Dr.
Hudson,  NH  03051
Applicant Contact JOSEPH P PAOLO
Correspondent
Innovative Gynecological Solutions, LLC
5 Wentworth Dr.
Hudson,  NH  03051
Correspondent Contact JOSEPH P PAOLO
Regulation Number884.4530
Classification Product Code
HIB  
Date Received01/18/2006
Decision Date 05/04/2006
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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