The following data is part of a premarket notification filed by Pennine Medical Ltd. with the FDA for Pennine Nelaton Catheters Sizes 5,6,8,10,12,14,16,.
| Device ID | K844876 |
| 510k Number | K844876 |
| Device Name: | PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, |
| Classification | Catheter, Irrigation |
| Applicant | PENNINE MEDICAL LTD. PONTEFRACT ST.ASCOT DR.IND.ESATE Derby, GB |
| Contact | Terry Morgan |
| Correspondent | Terry Morgan PENNINE MEDICAL LTD. PONTEFRACT ST.ASCOT DR.IND.ESATE Derby, GB |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-17 |
| Decision Date | 1985-06-05 |