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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 K130046
Device Name CLEARSPEC SINGLE USE VAGINAL SPECULUM
Applicant
Clearspec, LLC
603 Grant St.
Herkimer,  NY  13350
Applicant Contact IRA DUESLER
Correspondent
Clearspec, LLC
603 Grant St.
Herkimer,  NY  13350
Correspondent Contact IRA DUESLER
Regulation Number884.4530
Classification Product Code
HIB  
Date Received01/08/2013
Decision Date 08/06/2013
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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