FDA 510(k) Application Details - K173225

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K173225
Device Name Tampon, Menstrual, Unscented
Applicant ALBAAD fem
1, Alon Hatavor St.
Caesarea Ind. Park 3800900 IL
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Contact Shlomo Helvits
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 10/03/2017
Decision Date 06/15/2018
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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