The following data is part of a premarket notification filed by Amerasia Corp. with the FDA for Niomed Shoe Covers.
| Device ID | K952897 |
| 510k Number | K952897 |
| Device Name: | NIOMED SHOE COVERS |
| Classification | Cover, Shoe, Operating-room |
| Applicant | AMERASIA CORP. 14228 MAC DEVITT ST. Baldwin Park, CA 91706 |
| Contact | David Song |
| Correspondent | David Song AMERASIA CORP. 14228 MAC DEVITT ST. Baldwin Park, CA 91706 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-23 |
| Decision Date | 1995-10-23 |