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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 K021849
Device Name TAGG DISPOSABLE VAGINAL SPECULUM
Applicant
TAGG INDUSTRIES
23210 DEL LAGO
LAGUNA HILLS,  CA  92653
Applicant Contact TERRY L SHIRLEY
Correspondent
TAGG INDUSTRIES
23210 DEL LAGO
LAGUNA HILLS,  CA  92653
Correspondent Contact TERRY L SHIRLEY
Regulation Number884.4530
Classification Product Code
HIB  
Date Received06/05/2002
Decision Date 07/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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