Ammi Magni-Guard
FDA 510(k) K961454 · American Medical Mfg., Inc.
510(k) numberK961454
Submission
- Device name
- Ammi Magni-Guard
- Applicant
- American Medical Mfg., Inc.
Chatsworth, CA, US - Received
- April 15, 1996
- Decision date
- July 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K945302 | Sloan Sta-Dri Pant ProtectorLYU · Traditional | Sloan Corp. | 03/19/1996SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K982029 | Sharps Collection Container - Saf-T-ShellFMI · Traditional | 04/06/1999SE |
| K915066 | Disposable Skin MarkerFZZ · Traditional | 05/14/1992SE |
| K915064 | Disposable Cautery Abrasive PadKDC · Traditional | 03/11/1992SE |
| K915065 | I.V.Irrigation PoleFOZ · Traditional | 02/11/1992SE |
| K915068 | Plastic Disposable Surgical Light Handle CoverFTA · Traditional | 02/06/1992SE |
Questions and answers
When was Ammi Magni-Guard cleared by the FDA?
Ammi Magni-Guard (K961454) received a 510(k) decision of Substantially Equivalent on July 25, 1996, 101 days after the submission was received.
What is the product code of K961454?
The FDA product code is LYU – Accessory, Surgical Apparel, a Class I (low risk) device regulated under 21 CFR 878.4040.