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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K050355
Device Name PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150
Applicant
TISSUE SCIENCE LABORATORIES, PLC
1141 CLARK STREET, SUITE D
COVINGTON,  GA  30014
Applicant Contact VICTORIA TAYLOR
Correspondent
TISSUE SCIENCE LABORATORIES, PLC
1141 CLARK STREET, SUITE D
COVINGTON,  GA  30014
Correspondent Contact VICTORIA TAYLOR
Regulation Number884.5980
Classification Product Code
PAI  
Date Received02/14/2005
Decision Date 03/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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