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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 K252005
Device Name Livi Device
Applicant
Liviwell, Inc.
333 Us Hwy. 46
Suite 201
Mountain Lakes,  NJ  07046
Applicant Contact Michael Ingber
Correspondent
Regulatory and Technical Associates
14 Somerset Ln.
Old Lyme,  CT  06371
Correspondent Contact Chris Staab
Regulation Number884.5470
Classification Product Code
HEB  
Date Received06/27/2025
Decision Date 03/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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