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FDA 510(k) Application Details - K022643
Device Classification Name
Microtools, Assisted Reproduction (Pipettes)
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510(K) Number
K022643
Device Name
Microtools, Assisted Reproduction (Pipettes)
Applicant
SWEMED LAB INTERNATIONAL AB
555 13TH ST. N.W.
WASHINGTON, DC 20004 US
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Contact
HOWARD M HOLSTEIN
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Regulation Number
884.6130
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Classification Product Code
MQH
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More FDA Info for this Product Code
Date Received
08/08/2002
Decision Date
11/05/2002
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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