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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Suction, Uterine
510(k) Number K161106
Device Name PANPAC DISPOSABLE VACUUM CURETTES
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 Number884.5070
Classification Product Code
HGH  
Date Received04/19/2016
Decision Date 01/13/2017
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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