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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 K150153
Device Name Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant
Applicant
Package Solutions LLC
2131 Blount Road
Pompano Beach,  FL  33069
Applicant Contact Jack Scalisi
Correspondent
Package Solutions LLC
2131 Blount Road
Pompano Beach,  FL  33069
Correspondent Contact Jack Scalisi
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/23/2015
Decision Date 10/20/2015
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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