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FDA 510(k) Application Details - K033776
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K033776
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
INSTEAD, INC.
4370 LA JOLLA VILLAGE DR.
SUITE 960
SAN DIEGO, CA 92122 US
Other 510(k) Applications for this Company
Contact
JOE PIKE
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
NUC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/03/2003
Decision Date
06/25/2004
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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