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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 K843388
Device Name WELLINGTON HOSPITAL PATTERN SELF-RETAIN
Applicant
DOWNS SURGICAL LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DOWNS SURGICAL LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.4520
Classification Product Code
HDF  
Date Received08/29/1984
Decision Date 10/01/1984
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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