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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tampon, Menstrual, Unscented
510(k) Number K173225
Device Name Interlude and private label Unscented 3-piece compact applicator tampon
Applicant
Albaad Fem
1, Alon Hatavor St.
Caesarea Ind. Park,  IL 3800900
Applicant Contact Shlomo Helvits
Correspondent
Regulatory Technical Associates
30 Neck Rd.
Old Lyme,  CT  06371
Correspondent Contact Robert J. Staab
Regulation Number884.5470
Classification Product Code
HEB  
Date Received10/03/2017
Decision Date 06/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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