The following data is part of a premarket notification filed by Stahmer Weston Scientific with the FDA for Ultrafit Liners.
| Device ID | K954314 |
| 510k Number | K954314 |
| Device Name: | ULTRAFIT LINERS |
| Classification | Accessory, Surgical Apparel |
| Applicant | STAHMER WESTON SCIENTIFIC 170 WEST RD. Portsmouth, NH 03801 |
| Contact | Fred Weston |
| Correspondent | Fred Weston STAHMER WESTON SCIENTIFIC 170 WEST RD. Portsmouth, NH 03801 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-15 |
| Decision Date | 1995-12-28 |