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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 K211519
Device Name Every Cycle Reusable Tampon Applicator
Applicant
Cycle, LLC
1927 Washington Avenue
Santa Monica,  CA  90403
Applicant Contact Jessica Samson
Correspondent
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact Gabriela McCoole
Regulation Number884.5470
Classification Product Code
HEB  
Subsequent Product Code
HIL  
Date Received05/17/2021
Decision Date 08/13/2021
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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