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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 K173351
Device Name Panpac Flexi Shelf Pessary
Applicant
Panpac Medical Corporation
6F-1,-2, No. 202, Sec. 3,
Ta-Tong Rd.
Shi-Chih Dist.,  TW 22103
Applicant Contact Yen-Ming Pan
Correspondent
Panpac Medical Corporation
6F-1,-2, No. 202, Sec. 3,
Ta-Tong Rd.
Shi-Chih Dist.,  TW 22103
Correspondent Contact Yen-Ming Pan
Regulation Number884.3575
Classification Product Code
HHW  
Date Received10/25/2017
Decision Date 10/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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