510(k) K870103
- Device
- LEAD APRON CADDY
- Applicant
- ORTHOPEDIC SYSTEMS, INC.
- 510(k) number
- K870103
- Product code
- EAJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-01-21
- Date received
- 1987-01-09
- Regulation
- 892.6500
- Classification name
- Apron, Leaded
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT R MOORE
- Address
- 1897 National Ave. Hayward CA US 94545 94545
FDA Registration Numbers#
- 9680506
- 3020118
- 8010704
- 1225473
- 3031564213
- 1219113
- 3025001668
- 3005908723
- 1417592
- 3002532594
- 2024351
- 3035678069
- 2182318
- 3017181414
- 2431224
- 1222742
- 3009171220
- 3031582434
- 1053541
- 3004183518
- 3010699203
- 1218386
- 9611503
- 3006897996
- 3026030534
- 3014680784
- 3013600135
- 3010598169
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EAJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931269 | LEAD APRON | Bt Medical Co., Inc. | 1993-06-02 |
| K913621 | RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR | Rinn Dental Products | 1991-09-27 |
| K870563 | X-RAY APRON | X-Tech, Ltd. | 1987-02-19 |
| K832601 | LEADED X-RAY APRON | E.M. Adams | 1983-09-29 |
| K832602 | THYROID PROTECTIVE COLLAR | E.M. Adams | 1983-09-29 |
Legacy Summary#
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FDA Review#
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