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FDA 510(k) Application Details - K001533
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K001533
Device Name
Insufflator, Laparoscopic
Applicant
W.O.M. GMHB
194 BRANCH ST.
MANSFIELD, MA 02048 US
Other 510(k) Applications for this Company
Contact
MICHAEL MCGRAIL
Other 510(k) Applications for this Contact
Regulation Number
884.1730
More FDA Info for this Regulation Number
Classification Product Code
HIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2000
Decision Date
07/31/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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