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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 K092981
Device Name PANPAC VAGINAL PESSARY
Applicant
Panpac Medical Corporation
# 202, 6f-1.2, Sec.3
Tatong Rd.
Shi-Chih City, Taipei Hsien,  TW 22103
Applicant Contact Yen-Ming Pan
Correspondent
Panpac Medical Corporation
# 202, 6f-1.2, Sec.3
Tatong Rd.
Shi-Chih City, Taipei Hsien,  TW 22103
Correspondent Contact Yen-Ming Pan
Regulation Number884.3575
Classification Product Code
HHW  
Date Received09/28/2009
Decision Date 07/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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