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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 K042950
Device Name VAG O SPECULUM, MODELS VS1, VM1, VL1
Applicant
PANATREX, INC.
1648 SIERRA MADRE CIR.
PLACENTIA,  CA  92870 -6626
Applicant Contact KEVIN KUO
Correspondent
PANATREX, INC.
1648 SIERRA MADRE CIR.
PLACENTIA,  CA  92870 -6626
Correspondent Contact KEVIN KUO
Regulation Number884.4530
Classification Product Code
HIB  
Date Received10/26/2004
Decision Date 11/30/2004
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
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