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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K092984
Device Name PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
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 Number884.4530
Classification Product Code
LKF  
Date Received09/28/2009
Decision Date 04/07/2010
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
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