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FDA 510(k) Application Details - K980061
Device Classification Name
Cannula, Intrauterine Insemination
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510(K) Number
K980061
Device Name
Cannula, Intrauterine Insemination
Applicant
ROCKET MEDICAL PLC
1151 HOPE ST.
STAMFORD, CT 06907 US
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Contact
R KEEN
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Regulation Number
884.5250
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Classification Product Code
MFD
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More FDA Info for this Product Code
Date Received
01/07/1998
Decision Date
03/02/1998
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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