Sloan Sta-Dri Pant Protector
FDA 510(k) K945302 · Sloan Corp.
510(k) numberK945302
Submission
- Device name
- Sloan Sta-Dri Pant Protector
- Applicant
- Sloan Corp.
Omaha, NE, US - Received
- August 30, 1994
- Decision date
- March 19, 1996
- 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
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|---|---|---|---|
| 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 |
| K954314 | Ultrafit LinersLYU · Traditional | Stahmer Weston Scientific | 12/28/1995SE |
| 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 |
More from Thantex Specialties, Inc.
Questions and answers
When was Sloan Sta-Dri Pant Protector cleared by the FDA?
Sloan Sta-Dri Pant Protector (K945302) received a 510(k) decision of Substantially Equivalent on March 19, 1996, 567 days after the submission was received.
What is the product code of K945302?
The FDA product code is LYU – Accessory, Surgical Apparel, a Class I (low risk) device regulated under 21 CFR 878.4040.