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FDA 510(k) Application Details - K010053
Device Classification Name
Insufflator, Laparoscopic
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510(K) Number
K010053
Device Name
Insufflator, Laparoscopic
Applicant
NORTHGATE TECHNOLOGIES, INC.
600 CHURCH RD.
ELGIN, IL 60123 US
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Contact
CASEY KUREK
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Regulation Number
884.1730
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Classification Product Code
HIF
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More FDA Info for this Product Code
Date Received
01/08/2001
Decision Date
10/23/2001
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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