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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 K863274
Device Name MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM
Original Applicant
MARTIN MEDICAL
36270 w. 103rd st.
p.o. box 590
desoto,  KS  66018
Original Contact randy kilburn
Regulation Number884.4530
Classification Product Code
HIB  
Date Received08/25/1986
Decision Date 09/02/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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