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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, Gamete, Fertilization, And Embryo Compatible
510(k) Number K051436
Device Name PRE' VAGINAL LUBRICANT
Applicant
Ingfertlity, LLC
17206 S. Spangle Creek Rd.
Valleyford,  WA  99036
Applicant Contact DENNIS CLIFTON
Correspondent
Ingfertlity, LLC
17206 S. Spangle Creek Rd.
Valleyford,  WA  99036
Correspondent Contact DENNIS CLIFTON
Regulation Number884.5300
Classification Product Code
PEB  
Date Received06/01/2005
Decision Date 10/13/2006
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
Recalls CDRH Recalls
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