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FDA 510(k) Application Details - K113036
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K113036
Device Name
Tampon, Menstrual, Unscented
Applicant
KIMBERLY-CLARK CORPORATION
2001 MARATHON AVE
NEEAH, WI 54956 US
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Contact
LORI BARR
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Regulation Number
884.5470
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Classification Product Code
HEB
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Date Received
10/12/2011
Decision Date
11/02/2011
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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