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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 K153422
Device Name Panpac Disposable Pessary Fitting Set
Applicant
Panpac Medical Corporation
6f-1,2, # 202, Sec.3, Ta-Tong Rd.
Shi-Chih Dist.,  TW 22103
Applicant Contact YEN-MING PAN
Correspondent
Panpac Medical Corporation
6f-1,2, # 202, Sec.3, Ta-Tong Rd.
Shi-Chih Dist.,  TW 22103
Correspondent Contact YEN-MING PAN
Regulation Number884.3575
Classification Product Code
HHW  
Date Received11/25/2015
Decision Date 07/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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