The following data is part of a premarket notification filed by Techstyles with the FDA for Gown Back, Model 13-403n; 13-404n; 13-405n.
| Device ID | K992436 |
| 510k Number | K992436 |
| Device Name: | GOWN BACK, MODEL 13-403N; 13-404N; 13-405N |
| Classification | Gown, Surgical |
| Applicant | TECHSTYLES 16415 ADDISON RD., #850 Addison, TX 75001 |
| Contact | Stephanie T Howard |
| Correspondent | Stephanie T Howard TECHSTYLES 16415 ADDISON RD., #850 Addison, TX 75001 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-22 |
| Decision Date | 2000-01-20 |
| Summary: | summary |