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FDA 510(k) Application Details - K011519
Device Classification Name
Pump, Breast, Non-Powered
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510(K) Number
K011519
Device Name
Pump, Breast, Non-Powered
Applicant
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE, IL 60048 US
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Contact
JOSEPH S TOKARZ
Other 510(k) Applications for this Contact
Regulation Number
884.5150
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Classification Product Code
HGY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2001
Decision Date
08/15/2001
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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