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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K142473
Device Name Lubricating Jelly
Applicant
Sion Biotext Medical , Ltd.
Kibbutz Hagoshrim
Upper Galilee,  IL 12225
Applicant Contact NADAV REUBEN
Correspondent
Talmed , Ltd.
M.P Upper Galilee
Ramot Naftali,  IL 1383000
Correspondent Contact TALI HAZAN
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received09/03/2014
Decision Date 04/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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