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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 K152628
Device Name Pulse H20h!
Applicant
Toaster Labs, Inc.
2212 Queen Anne Ave. N., #269
Seattle,  WA  98109
Applicant Contact AMY C. BUCKALTER
Correspondent
Toaster Labs, Inc.
2212 Queen Anne Ave. N., #269
Seattle,  WA  98109
Correspondent Contact AMY C. BUCKALTER
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/15/2015
Decision Date 07/11/2016
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
Predetermined Change
Control Plan Authorized		 No
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