The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Compe1 1 -ply Surgical Gowns.
| Device ID | K060181 |
| 510k Number | K060181 |
| Device Name: | COMPE1 1 -PLY 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 | 2006-01-23 |
| Decision Date | 2006-03-07 |
| Summary: | summary |