Davis Lead Apron/Radiographic Various Cat. Numbers
FDA 510(k) K912378 · Davis Lead Aprons, Inc.
510(k) numberK912378
Submission
- Device name
- Davis Lead Apron/Radiographic Various Cat. Numbers
- Applicant
- Davis Lead Aprons, Inc.
Houston, TX, US - Received
- May 29, 1991
- Decision date
- March 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
| 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 Davis Lead Apron/Radiographic Various Cat. Numbers cleared by the FDA?
Davis Lead Apron/Radiographic Various Cat. Numbers (K912378) received a 510(k) decision of Substantially Equivalent on March 18, 1992, 294 days after the submission was received.
What is the product code of K912378?
The FDA product code is KPY – Shield, Protective, Personnel, a Class I (low risk) device regulated under 21 CFR 892.6500.