Lead Apron Caddy
FDA 510(k) K870103 · Orthopedic Systems, Inc.
510(k) numberK870103
Submission
- Device name
- Lead Apron Caddy
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- January 9, 1987
- Decision date
- January 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931269 | Lead ApronEAJ · Traditional | Bt Medical Co., Inc. | 06/02/1993SE |
| K913621 | Rinn Protective X-Ray Apron and Protective CollarEAJ · Traditional | Rinn Dental Products | 09/27/1991SE |
| K870563 | X-Ray ApronEAJ · Traditional | X-Tech, Ltd. | 02/19/1987SE |
| K832602 | Thyroid Protective CollarEAJ · Traditional | E.M. Adams | 09/29/1983SE |
| K832601 | Leaded X-Ray ApronEAJ · Traditional | E.M. Adams | 09/29/1983SE |
More from E.M. Adams
| 510(k) | Device | Decision |
|---|---|---|
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | 08/10/1992SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | 05/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
Questions and answers
When was Lead Apron Caddy cleared by the FDA?
Lead Apron Caddy (K870103) received a 510(k) decision of Substantially Equivalent on January 21, 1987, 12 days after the submission was received.
What is the product code of K870103?
The FDA product code is EAJ – Apron, Leaded, a Class I (low risk) device regulated under 21 CFR 892.6500.