The following data is part of a premarket notification filed by Penny And Giles Biometrics Ltd. with the FDA for Ule-2, Mule-2, Hand Accessory Kit.
| Device ID | K962855 |
| 510k Number | K962855 |
| Device Name: | ULE-2, MULE-2, HAND ACCESSORY KIT |
| Classification | Exerciser, Measuring |
| Applicant | PENNY AND GILES BIOMETRICS LTD. NEWBRIDGE ROAD, BLACKWOOD Gwent, Wales, GB Np2 2yd |
| Contact | Ian Thomas |
| Correspondent | Ian Thomas PENNY AND GILES BIOMETRICS LTD. NEWBRIDGE ROAD, BLACKWOOD Gwent, Wales, GB Np2 2yd |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-22 |
| Decision Date | 1996-12-11 |
| Summary: | summary |