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FDA 510(k) Application Details - K980395
Device Classification Name
Pad, Menstrual, Unscented
More FDA Info for this Device
510(K) Number
K980395
Device Name
Pad, Menstrual, Unscented
Applicant
KEEPERS!, INC.
2110 N. WILLIAMS
P O BOX 12648
PORTLAND, OR 97212 US
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Contact
BRENDA MALLORY
Other 510(k) Applications for this Contact
Regulation Number
884.5435
More FDA Info for this Regulation Number
Classification Product Code
HHD
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More FDA Info for this Product Code
Date Received
02/02/1998
Decision Date
04/16/1998
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
FDA Source Information for K980395
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