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FDA 510(k) Application Details - K061486
Device Classification Name
Tampon, Menstrual, Unscented
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510(K) Number
K061486
Device Name
Tampon, Menstrual, Unscented
Applicant
PROCTER & GAMBLE CO.
2001 PENNSYLVANIA AVE, STE 575
WASHINGTON, DC 20006 US
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Contact
PHILIP J PHILLIPS
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Regulation Number
884.5470
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Classification Product Code
HEB
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Date Received
05/31/2006
Decision Date
08/01/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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