The following data is part of a premarket notification filed by Simpla Plastics Ltd. with the FDA for Simpla S4, S5, S7.
| Device ID | K941447 |
| 510k Number | K941447 |
| Device Name: | SIMPLA S4, S5, S7 |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | SIMPLA PLASTICS LTD. CARDIFF BUSINESS PARK Cardiff, GB Cf4 5wf |
| Contact | Richard Hunter |
| Correspondent | Richard Hunter SIMPLA PLASTICS LTD. CARDIFF BUSINESS PARK Cardiff, GB Cf4 5wf |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1994-07-18 |