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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lubricant, personal
510(k) Number K211967
Device Name Sensual Massage, Ultra Pure
Dreambrands, Inc.
11645 N. Cave Creek Road
Phoenix,  AZ  85020
Applicant Contact Cecile Kehoe
Wagoner Consulting LLG
PO Box 15729
Wilmington,  NC  28408
Correspondent Contact Cheryl Wagoner
Regulation Number884.5300
Classification Product Code
Date Received06/24/2021
Decision Date 11/09/2021
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