Davis Lead Apron - Various Catalogue Numbers
FDA 510(k) K912326 · Davis Lead Aprons, Inc.
510(k) numberK912326
Submission
- Device name
- Davis Lead Apron - Various Catalogue Numbers
- Applicant
- Davis Lead Aprons, Inc.
Houston, TX, US - Received
- May 24, 1991
- Decision date
- March 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KPY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110900 | Disposable Thyroid CollarKPY · Traditional | Bloxr Corporation | 06/24/2011SE |
| K962622 | Intra-Oral Thermoplastic ShieldKPY · Traditional | Medtec, Inc. | 10/01/1996SE |
| K954456 | Thermoplastic ShieldKPY · Traditional | Medtec, Inc. | 12/21/1995SE |
| K954146 | Utk-Dte Autilary ShieldKPY · Traditional | Mallinckrodt Medical | 12/06/1995SE |
| K953610 | AukulyteKPY · Traditional | Aukland Medical Plastics, Inc. | 09/26/1995SE |
| 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 |
More from Davis Lead Aprons, Inc.
Questions and answers
When was Davis Lead Apron - Various Catalogue Numbers cleared by the FDA?
Davis Lead Apron - Various Catalogue Numbers (K912326) received a 510(k) decision of Substantially Equivalent on March 18, 1992, 299 days after the submission was received.
What is the product code of K912326?
The FDA product code is KPY – Shield, Protective, Personnel, a Class I (low risk) device regulated under 21 CFR 892.6500.