The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Compel 3000 Surgical Gown, Compel 2g Surgical Gowns.
| Device ID | K945371 |
| 510k Number | K945371 |
| Device Name: | COMPEL 3000 SURGICAL GOWN, COMPEL 2G 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 | 1994-11-02 |
| Decision Date | 1995-04-27 |