The following data is part of a premarket notification filed by Precept Medical Products, Inc. with the FDA for Ultragard Impervious Reinforced Gown.
| Device ID | K013846 |
| 510k Number | K013846 |
| Device Name: | ULTRAGARD IMPERVIOUS REINFORCED GOWN |
| Classification | Gown, Surgical |
| Applicant | PRECEPT MEDICAL PRODUCTS, INC. 370 AIRPORT RD. Arden, NC 28704 |
| Contact | Mary Ann Faulkner |
| Correspondent | Mary Ann Faulkner PRECEPT MEDICAL PRODUCTS, INC. 370 AIRPORT RD. Arden, NC 28704 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-20 |
| Decision Date | 2002-05-22 |
| Summary: | summary |