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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.
Pkwy. Close,Pkwy.
Industrial Estate
Sheffield S9 4wj,  GB
Applicant Contact GEOFFREY W DOWN
Correspondent
Downs Surgical , Ltd.
Pkwy. Close,Pkwy.
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
Predetermined Change
Control Plan Authorized		 No
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