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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 K981549
Device Name LACTATION TECHNIQUES MODEL B
Applicant
LACTATION TECHNIQUES, INC.
1252 WEST 50 SOUTH
SALT LAKE CITY,  UT  84014
Applicant Contact MARK LELOUDIS
Correspondent
LACTATION TECHNIQUES, INC.
1252 WEST 50 SOUTH
SALT LAKE CITY,  UT  84014
Correspondent Contact MARK LELOUDIS
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/30/1998
Decision Date 05/24/1999
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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