The following data is part of a premarket notification filed by Kenex Ltd. with the FDA for Kenex Radiation Shield (various Models As Exhibits #2 & 5).
| Device ID | K951003 |
| 510k Number | K951003 |
| Device Name: | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) |
| Classification | Shield, Protective, Personnel |
| Applicant | KENEX LTD. LANGLEY HOUSE 24 BURNT MILL HARLOW ESSEX CM20 2HS England, GB |
| Contact | K. C. Hunt |
| Correspondent | K. C. Hunt KENEX LTD. LANGLEY HOUSE 24 BURNT MILL HARLOW ESSEX CM20 2HS England, GB |
| Product Code | KPY |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-15 |
| Decision Date | 1995-04-03 |