The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Compel Surgical Drapes.
Device ID | K923811 |
510k Number | K923811 |
Device Name: | COMPEL SURGICAL DRAPES |
Classification | Drape, 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 | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-29 |
Decision Date | 1993-02-23 |