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FDA 510(k) Application Details - K112635
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K112635
Device Name
Tampon, Menstrual, Unscented
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE ROAD
ROSWELL, GA 30076 US
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Contact
Swarna Mukund
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Regulation Number
884.5470
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Classification Product Code
HEB
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More FDA Info for this Product Code
Date Received
09/09/2011
Decision Date
10/07/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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