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FDA 510(k) Application Details - K971543
Device Classification Name
Pump, Breast, Powered
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510(K) Number
K971543
Device Name
Pump, Breast, Powered
Applicant
KAWECO GMBH
55 NORTHERN BLVD., SUITE 410
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
884.5160
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Classification Product Code
HGX
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More FDA Info for this Product Code
Date Received
04/28/1997
Decision Date
09/18/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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