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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K072762
Device Name DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
Applicant
Depalt, Inc.
5013 Stonewick Ct.
Plano,  TX  75093
Applicant Contact RAJEEV PATEL
Correspondent
Depalt, Inc.
5013 Stonewick Ct.
Plano,  TX  75093
Correspondent Contact RAJEEV PATEL
Regulation Number884.4530
Classification Product Code
HIB  
Date Received09/28/2007
Decision Date 01/22/2008
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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