The following data is part of a premarket notification filed by Liaoning-usa Corp. with the FDA for Disposable Isolation Gown.
| Device ID | K911921 |
| 510k Number | K911921 |
| Device Name: | DISPOSABLE ISOLATION GOWN |
| Classification | Gown, Patient |
| Applicant | LIAONING-USA CORP. 123 WEST BELLEVUE, UNIT#4 Pasadena, CA 91105 -2549 |
| Contact | Jay A Brown |
| Correspondent | Jay A Brown LIAONING-USA CORP. 123 WEST BELLEVUE, UNIT#4 Pasadena, CA 91105 -2549 |
| Product Code | FYB |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-30 |
| Decision Date | 1991-05-13 |