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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 K030693
Device Name KENTEX DISPOSABLE VAGINAL SPECULUM
Applicant
Kentron Health Care, Inc.
3604 Kelton Jackson Rd.
Springfield,  TN  37172
Applicant Contact DR. SADARANGANI
Correspondent
Kentron Health Care, Inc.
3604 Kelton Jackson Rd.
Springfield,  TN  37172
Correspondent Contact DR. SADARANGANI
Regulation Number884.4530
Classification Product Code
HIB  
Date Received03/05/2003
Decision Date 08/27/2003
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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