The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Modification To: Compel Surgical Drapes.
| Device ID | K012807 |
| 510k Number | K012807 |
| Device Name: | MODIFICATION TO: 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-22 |
| Decision Date | 2001-10-11 |
| Summary: | summary |