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FDA 510(k) Application Details - K000199
Device Classification Name
Laparoscope, Gynecologic (And Accessories)
More FDA Info for this Device
510(K) Number
K000199
Device Name
Laparoscope, Gynecologic (And Accessories)
Applicant
CORTEK ENDOSCOPY, INC.
501 W. COLFAX, SUITE B
PALATINE, IL 60067 US
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Contact
CORNEL M TOPALA
Other 510(k) Applications for this Contact
Regulation Number
884.1720
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Classification Product Code
HET
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/21/2000
Decision Date
04/13/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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