Ultrafit Liners
FDA 510(k) K954314 · Stahmer Weston Scientific
510(k) numberK954314
Submission
- Device name
- Ultrafit Liners
- Applicant
- Stahmer Weston Scientific
Portsmouth, NH, US - Received
- September 15, 1995
- Decision date
- December 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LYU – Accessory, Surgical Apparel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LYU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011755 | Stryker T4 Hytrel (R) TogasLYU · Special | Stryker Corp. | 06/22/2001SE |
| K965237 | Nurses Bouffant CapLYU · Traditional | Copioumed Intl., Inc. | 08/27/1997SE |
| K970988 | Far-East Bouffant CapsLYU · Traditional | Far East Science & Technology Development Co.… | 07/10/1997SE |
| K964364 | Disposable ApronLYU · Traditional | Instrument Makar, Inc. | 02/25/1997SE |
| K961791 | Depuy Disposable Filter/HoodLYU · Traditional | Depuy, Inc. | 08/09/1996SE |
| K961454 | Ammi Magni-GuardLYU · Traditional | American Medical Mfg., Inc. | 07/25/1996SE |
| K945302 | Sloan Sta-Dri Pant ProtectorLYU · Traditional | Sloan Corp. | 03/19/1996SE |
| K953089 | I-SpouseLYU · Traditional | Products For Medicine | 10/16/1995SE |
| K952303 | Splash AssistLYU · Traditional | Innovative Outsourcing Solutions | 08/24/1995SE |
| K942200 | Isolyser Orex Surgeon's Caps, Hoods, Bouffant CapsLYU · Traditional | Thantex Specialties, Inc. | 08/07/1995SE |
Questions and answers
When was Ultrafit Liners cleared by the FDA?
Ultrafit Liners (K954314) received a 510(k) decision of Substantially Equivalent on December 28, 1995, 104 days after the submission was received.
What is the product code of K954314?
The FDA product code is LYU – Accessory, Surgical Apparel, a Class I (low risk) device regulated under 21 CFR 878.4040.