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FDA 510(k) Application Details - K011938
Device Classification Name
Media, Reproductive
More FDA Info for this Device
510(K) Number
K011938
Device Name
Media, Reproductive
Applicant
IRVINE SCIENTIFIC SALES CO., INC.
2511 DAIMLER ST.
SANTA ANA, CA 92705 US
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Contact
WENDELL LEE
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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
06/21/2001
Decision Date
07/18/2001
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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