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FDA 510(k) Application Details - K974227
Device Classification Name
Clamp, Umbilical
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510(K) Number
K974227
Device Name
Clamp, Umbilical
Applicant
GPS
11 LOWELL RD.
PORT WASHINGTON, NY 11050 US
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Contact
LOUIS PAGLIARA
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Regulation Number
884.4530
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Classification Product Code
HFW
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More FDA Info for this Product Code
Date Received
11/12/1997
Decision Date
12/12/1997
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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