FDA 510(k) Application Details - K981549

Device Classification Name Pump, Breast, Powered

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510(K) Number K981549
Device Name Pump, Breast, Powered
Applicant LACTATION TECHNIQUES, INC.
1252 WEST 50 SOUTH
SALT LAKE CITY, UT 84014 US
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Contact MARK LELOUDIS
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 04/30/1998
Decision Date 05/24/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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