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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, metal
510(k) Number K853640
Device Name WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL
Applicant
DOWNS SURGICAL LTD.
PARKWAY CLOSE,PARKWAY
INDUSTRIAL ESTATE
SHEFFIELD S9 4WJ,  GB
Applicant Contact GEOFFREY W DOWN
Correspondent
DOWNS SURGICAL LTD.
PARKWAY CLOSE,PARKWAY
INDUSTRIAL ESTATE
SHEFFIELD S9 4WJ,  GB
Correspondent Contact GEOFFREY W DOWN
Regulation Number884.4520
Classification Product Code
HDF  
Date Received08/20/1985
Decision Date 10/29/1985
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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