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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pessary, Vaginal
510(k) Number K012277
Device Name PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
Applicant
SIMS PORTEX LTD.
HYTHE
HYTHE, KENT,  GB CT 21 6JL
Applicant Contact STEVEN OGILVIE
Correspondent
SIMS PORTEX LTD.
HYTHE
HYTHE, KENT,  GB CT 21 6JL
Correspondent Contact STEVEN OGILVIE
Regulation Number884.3575
Classification Product Code
HHW  
Date Received07/19/2001
Decision Date 02/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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