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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 K191431
Device Name Interlude Rolled Tampons in Plastic Applicator
Applicant
ALBAAD fem
1, Alon Hatavor St.
Caesarea Ind. Park,  IL 3088900
Applicant Contact Shlomo Helvits
Correspondent
Regulatory Technical Associates
30 Neck Road
Old Lyme,  CT  06371
Correspondent Contact Robert. J. Staab
Regulation Number884.5470
Classification Product Code
HEB  
Date Received05/29/2019
Decision Date 10/07/2019
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
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