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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 K862478
Device Name HAYES VAGINAL SHIELD
Applicant
Franklin Medical USA, Inc.
26206 W. 12 Mile Rd.
Suite 200
Southfield,  MI  48034
Applicant Contact HAYES, M.D.
Correspondent
Franklin Medical USA, Inc.
26206 W. 12 Mile Rd.
Suite 200
Southfield,  MI  48034
Correspondent Contact HAYES, M.D.
Regulation Number884.4520
Classification Product Code
HDF  
Date Received06/30/1986
Decision Date 11/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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