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FDA 510(k) Application Details - K050211
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
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510(K) Number
K050211
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
QUALIS, INC.
4600 PARK AVE.
DES MOINES, IA 50321 US
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Contact
MIKE PETERSON
Other 510(k) Applications for this Contact
Regulation Number
884.5300
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Classification Product Code
NUC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/31/2005
Decision Date
03/17/2005
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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