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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
Models 590XX SERIES, 790 SERIES
Device Name SPECULUM, VAGINAL, NONMETAL
Applicant
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls,  NY  13153 0220
Contact kevin crossen
Regulation Number884.4530
Classification Product Code
HIB  
Date Received03/12/2012
Decision Date 03/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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