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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 K120743
Device Name SPECULUM, VAGINAL, NONMETAL
Original Applicant
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls,  NY  13153 -0220
Original Contact kevin crossen
Regulation Number884.4530
Classification Product Code
HIB  
Date Received03/12/2012
Decision Date 03/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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