The following data is part of a premarket notification filed by X-tech, Ltd. with the FDA for X-ray Apron.
| Device ID | K870563 |
| 510k Number | K870563 |
| Device Name: | X-RAY APRON |
| Classification | Apron, Leaded |
| Applicant | X-TECH, LTD. P.O. BOX 6069 Newburyport, MA 01950 |
| Contact | Preston Gill |
| Correspondent | Preston Gill X-TECH, LTD. P.O. BOX 6069 Newburyport, MA 01950 |
| Product Code | EAJ |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-10 |
| Decision Date | 1987-02-19 |