The following data is part of a premarket notification filed by Kenex Ltd. with the FDA for 2001 Special Procedure Lamp (low Voltage) (as Exhibits #2 & 4).
| Device ID | K951004 |
| 510k Number | K951004 |
| Device Name: | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) |
| Classification | Shield, Protective, Personnel |
| Applicant | KENEX LTD. LANGLEY HOUSE 24 BURNT MILL HARLOW ESSEX CM20 2HS England, DE |
| Contact | K.c. Hunt |
| Correspondent | K.c. Hunt KENEX LTD. LANGLEY HOUSE 24 BURNT MILL HARLOW ESSEX CM20 2HS England, DE |
| 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 | 1995-04-10 |