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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
Applicant
MARTIN MEDICAL
36270 W. 103RD ST.
P.O. BOX 590
DESOTO,  KS  66018
Applicant Contact RANDY KILBURN
Correspondent
MARTIN MEDICAL
36270 W. 103RD ST.
P.O. BOX 590
DESOTO,  KS  66018
Correspondent Contact RANDY KILBURN
Regulation Number884.4530
Classification Product Code
HIB  
Date Received08/25/1986
Decision Date 09/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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