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FDA 510(k) Application Details - K991273
Device Classification Name
Needle, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K991273
Device Name
Needle, Assisted Reproduction
Applicant
SWEMED LAB INTERNATIONAL AB
555 13TH ST. N.W.
WASHINGTON, DC 20004 US
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Contact
EDWARD C WILSON JR.
Other 510(k) Applications for this Contact
Regulation Number
884.6100
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Classification Product Code
MQE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/1999
Decision Date
08/18/1999
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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