COMPEL SURGICAL GOWNS

Gown, Surgical

STANDARD TEXTILE CO., INC.

The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Compel Surgical Gowns.

Pre-market Notification Details

• Device ID: K041539
• 510k Number: K041539
• Device Name: COMPEL SURGICAL GOWNS
• Classification: Gown, Surgical
• Applicant: STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600
• Contact: Bradley J Bushman
• Correspondent: Bradley J Bushman; STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600
• Product Code: FYA
• CFR Regulation Number: 878.4040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-06-08
• Decision Date: 2005-04-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00634916788358	K041539	000
00634916024449	K041539	000
00634916024456	K041539	000
00634916024470	K041539	000
00634916025262	K041539	000
00634916026085	K041539	000
00634916028416	K041539	000
00634916033229	K041539	000
00634916033236	K041539	000
00634916040043	K041539	000
00634916043211	K041539	000
00634916048117	K041539	000
00634916048124	K041539	000
00634916051650	K041539	000
00634916019360	K041539	000
00634916016741	K041539	000
00634916011296	K041539	000
00634916348491	K041539	000
00634916691641	K041539	000
00634916691658	K041539	000
00634916000337	K041539	000
00634916003789	K041539	000
00634916003796	K041539	000
00634916003802	K041539	000
00634916003819	K041539	000
00634916003826	K041539	000
00634916005752	K041539	000
00634916005837	K041539	000
00634916006018	K041539	000
00634916010923	K041539	000
00634916056310	K041539	000
00634916084184	K041539	000
00634916108316	K041539	000
00634916230420	K041539	000
00634916230437	K041539	000
00634916284539	K041539	000
00634916294989	K041539	000
00634916298048	K041539	000
00634916302677	K041539	000
00634916318760	K041539	000
00634916318784	K041539	000
00634916325881	K041539	000
00634916343175	K041539	000
00634916343236	K041539	000
00634916343250	K041539	000
00634916343274	K041539	000
00634916230413	K041539	000
00634916229998	K041539	000
00634916229981	K041539	000
00634916110159	K041539	000
00634916137163	K041539	000
00634916137217	K041539	000
00634916137224	K041539	000
00634916141887	K041539	000
00634916141894	K041539	000
00634916146639	K041539	000
00634916147605	K041539	000
00634916147629	K041539	000
00634916147636	K041539	000
00634916188226	K041539	000
00634916227031	K041539	000
00634916229974	K041539	000
00634916386196	K041539	000