Aukulyte
FDA 510(k) K953610 · Aukland Medical Plastics, Inc.
510(k) numberK953610
Submission
- Device name
- Aukulyte
- Applicant
- Aukland Medical Plastics, Inc.
Cary, NC, US - Received
- August 2, 1995
- Decision date
- September 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K110900 | Disposable Thyroid CollarKPY · Traditional | Bloxr Corporation | 06/24/2011SE |
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| K954456 | Thermoplastic ShieldKPY · Traditional | Medtec, Inc. | 12/21/1995SE |
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| K951004 | 2001 Special Procedure Lamp (Low Voltage) (AS Exhibits #2 & 4)KPY · Traditional | Kenex , Ltd. | 04/10/1995SE |
| K951003 | Kenex Radiation Shield (Various Models AS Exhibits #2 & 5)KPY · Traditional | Kenex , Ltd. | 04/03/1995SE |
| K940539 | Stand Imaging Dose Calibrator Shielded Work PlatformKPY · Traditional | Standard Imaging, Inc. | 03/16/1994SE |
| K934206 | Mavig Angio Shield Models 6290 & 6272KPY · Traditional | F. Walter Hanel GmbH | 10/07/1993SE |
| K912378 | Davis Lead Apron/Radiographic Various Cat. NumbersKPY · Traditional | Davis Lead Aprons, Inc. | 03/18/1992SE |
| K912327 | Davis Lead Apron Gonadal Shield-Various Cat. Nos.KPY · Traditional | Davis Lead Aprons, Inc. | 03/18/1992SE |
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Questions and answers
When was Aukulyte cleared by the FDA?
Aukulyte (K953610) received a 510(k) decision of Substantially Equivalent on September 26, 1995, 55 days after the submission was received.
What is the product code of K953610?
The FDA product code is KPY – Shield, Protective, Personnel, a Class I (low risk) device regulated under 21 CFR 892.6500.