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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 K150397
Device Name Divine 9
CarraShield Labs, Inc.
8815 Conroy Road
Orlando,  FL  32835
Applicant Contact Dean Fresonke
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number884.5300
Classification Product Code
Date Received02/18/2015
Decision Date 11/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No