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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 K132313
Device Name PESSARY
Applicant
EIS CORPORATION
#821 Samil Plaza, 837-26 Yeuksam-dong
Gangnam-gu, Seoul,  KR 135-768
Applicant Contact YANG HO DONG
Correspondent
EIS CORPORATION
#821 Samil Plaza, 837-26 Yeuksam-dong
Gangnam-gu, Seoul,  KR 135-768
Correspondent Contact YANG HO DONG
Regulation Number884.3575
Classification Product Code
HHW  
Date Received07/25/2013
Decision Date 12/05/2014
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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