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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 K132670
Device Name PANPAC INFLATABLE DOCUT PESSARY
Applicant
Panpac Medical Corporation
NO. 202, 6F-1.2, SEC.3
TATONG ROAD
SHI-CHIH CITY, TAIPEI HSIEN,  TW 22103
Applicant Contact Yen-Ming Pan
Correspondent
Panpac Medical Corporation
NO. 202, 6F-1.2, SEC.3
TATONG ROAD
SHI-CHIH CITY, TAIPEI HSIEN,  TW 22103
Correspondent Contact Yen-Ming Pan
Regulation Number884.3575
Classification Product Code
HHW  
Date Received08/27/2013
Decision Date 06/04/2014
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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