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FDA 510(k) Application Details - K993881
Device Classification Name
Labware, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K993881
Device Name
Labware, Assisted Reproduction
Applicant
INTL., INC.
170 FORT PATH RD.
UNIT 14
MADISON, CT 06443 US
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Contact
MICHAEL D CECCHI
Other 510(k) Applications for this Contact
Regulation Number
884.6160
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Classification Product Code
MQK
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More FDA Info for this Product Code
Date Received
11/16/1999
Decision Date
02/14/2000
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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