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FDA 510(k) Application Details - K042495
Device Classification Name
Media, Reproductive
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510(K) Number
K042495
Device Name
Media, Reproductive
Applicant
HALOZYME THERAPEUTICS INC.
11588 SORRENTO VALLEY RD. #17
SAN DIEGO, CA 92121 US
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Contact
DON KENNARD
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Regulation Number
884.6180
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Classification Product Code
MQL
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More FDA Info for this Product Code
Date Received
09/14/2004
Decision Date
04/14/2005
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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