FDA 510(k) Application Details - K980395

Device Classification Name Pad, Menstrual, Unscented

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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
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Regulation Number 884.5435

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Classification Product Code HHD
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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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