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FDA 510(k) Application Details - K974116
Device Classification Name
Pessary, Vaginal
More FDA Info for this Device
510(K) Number
K974116
Device Name
Pessary, Vaginal
Applicant
DESCHUTES MEDICAL PRODUCTS, INC.
1011 S.W. EMKAY DR., SUITE 104
BEND, OR 97702 US
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Contact
MATTHEW W HOSKINS
Other 510(k) Applications for this Contact
Regulation Number
884.3575
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Classification Product Code
HHW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/1997
Decision Date
04/27/1998
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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