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Standard Textile Co., Inc.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K241214 ProPel SG3™ Surgical GownFYA2024-09-10 View
510(k) K172207 Standard Supreme Sterilization WrapperFRG2017-08-25 View
510(k) K162162 Barrier Supreme Sterilization WrapperFRG2016-11-04 View
510(k) K060181 COMPE1 1 -PLY SURGICAL GOWNSFYA2006-03-07 View
510(k) K041653 COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNSFYA2005-07-01 View
510(k) K041540 COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNSFYA2005-05-05 View
510(k) K041539 COMPEL SURGICAL GOWNSFYA2005-04-28 View
510(k) K041541 COMPEL MLR SURGICAL GOWNSFYA2005-03-16 View
510(k) K012268 TRIMAXFYA2001-12-03 View
510(k) K012807 MODIFICATION TO: COMPEL SURGICAL DRAPESKKX2001-10-11 View
510(k) K010799 COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)FYA2001-06-07 View
510(k) K980183 PROMAX SURGICAL DRAPES AND COVERSKKX1998-02-26 View
510(k) K945371 COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNSFYA1995-04-27 View
510(k) K950504 PERVAL SURGICAL GOWN (MARKETING NAME)FYA1995-04-25 View
510(k) K944863 COMPEL SURGICALDRAPESKKX1995-02-28 View
510(k) K940758 COMPEL SURGICAL GOWNSFYA1994-04-22 View
510(k) K923408 WRAPPEL TFRG1993-04-08 View
510(k) K922753 COMPEL XTRFYA1993-03-09 View
510(k) K923811 COMPEL SURGICAL DRAPESKKX1993-02-23 View
510(k) K921889 COMPEL O AND RFYA1993-02-18 View
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