The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Combosafe Surgical Gowns, Non-sterile (75x Reusable).
| Device ID | K010799 |
| 510k Number | K010799 |
| Device Name: | COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) |
| Classification | Gown, Surgical |
| Applicant | STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Contact | Bradley J Buschman |
| Correspondent | Bradley J Buschman 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 | 2001-03-16 |
| Decision Date | 2001-06-07 |