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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K092783
Device Name DEBP
Applicant
Enko , Ltd.
10006 Sokak, #64,
A.O.S.B.
Cigli - Izmir,  TR 35620
Applicant Contact SINAN KAZAZOGLU
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/10/2009
Decision Date 10/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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