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FDA 510(k) Application Details - K991264
Device Classification Name
Needle, Assisted Reproduction
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510(K) Number
K991264
Device Name
Needle, 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
884.6100
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Classification Product Code
MQE
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More FDA Info for this Product Code
Date Received
04/13/1999
Decision Date
09/09/1999
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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