WRAPPEL T

Wrap, Sterilization

STANDARD TEXTILE CO., INC.

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

Pre-market Notification Details

• Device ID: K923408
• 510k Number: K923408
• Device Name: WRAPPEL T
• Classification: Wrap, Sterilization
• 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: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-07-10
• Decision Date: 1993-04-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00634916001327	K923408	000
00634916016673	K923408	000
00634916016680	K923408	000
00634916023657	K923408	000
00634916023664	K923408	000
00634916023671	K923408	000
00634916027624	K923408	000
00634916032550	K923408	000
00634916032567	K923408	000
00634916032574	K923408	000
00634916032581	K923408	000
00634916016666	K923408	000
00634916016543	K923408	000
00634916001334	K923408	000
00634916001341	K923408	000
00634916001358	K923408	000
00634916001365	K923408	000
00634916001372	K923408	000
00634916001389	K923408	000
00634916001396	K923408	000
00634916016512	K923408	000
00634916016529	K923408	000
00634916016536	K923408	000
00634916056273	K923408	000
00634916069280	K923408	000
00634916179910	K923408	000
00634916179927	K923408	000
00634916179934	K923408	000
00634916179941	K923408	000
00634916179958	K923408	000
00634916276053	K923408	000
00634916284270	K923408	000
00634916284287	K923408	000
00634916295078	K923408	000
00634916295085	K923408	000
00634916122916	K923408	000
00634916103946	K923408	000
00634916074123	K923408	000
00634916076097	K923408	000
00634916079982	K923408	000
00634916080018	K923408	000
00634916101706	K923408	000
00634916101713	K923408	000
00634916101720	K923408	000
00634916103106	K923408	000
00634916103236	K923408	000
00634916103939	K923408	000
00634916295092	K923408	000