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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 K052314
Device Name DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
Applicant
Dynarex Corp.
10 Glenshaw St.
Orangeburg,  NY  10962
Applicant Contact JAMES HURLMAN
Correspondent
Dynarex Corp.
10 Glenshaw St.
Orangeburg,  NY  10962
Correspondent Contact JAMES HURLMAN
Regulation Number884.4530
Classification Product Code
HIB  
Date Received08/25/2005
Decision Date 11/09/2005
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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