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FDA 510(k) Application Details - K112856
Device Classification Name
Pump, Breast, Powered
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510(K) Number
K112856
Device Name
Pump, Breast, Powered
Applicant
GENADYNE BIOTECHNOLOGIES, INC.
16 MIDLAND AVE
HICKSVILLE, NY 11801 US
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Contact
CHIEN-MING GOH
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
09/30/2011
Decision Date
05/10/2012
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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