The following data is part of a premarket notification filed by Amerasia Corp. with the FDA for Niomed Barrier Gowns.
| Device ID | K954747 |
| 510k Number | K954747 |
| Device Name: | NIOMED BARRIER GOWNS |
| Classification | Gown, Isolation, Surgical |
| Applicant | AMERASIA CORP. 4121 TIGRIS WAY Riverside, CA 92503 |
| Contact | David Song |
| Correspondent | David Song AMERASIA CORP. 4121 TIGRIS WAY Riverside, CA 92503 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1996-03-06 |