The following data is part of a premarket notification filed by Warne Surgical Products, Ltd. with the FDA for Wsp Code 4301 Diomaster Therapeutic.
| Device ID | K850695 |
| 510k Number | K850695 |
| Device Name: | WSP CODE 4301 DIOMASTER THERAPEUTIC |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | WARNE SURGICAL PRODUCTS, LTD. PORTADOWN ROAD, LURGAN, CRAIGAVON, CO. Armagh Bt66 8rd, IE |
| Contact | Lewis Hamilton |
| Correspondent | Lewis Hamilton WARNE SURGICAL PRODUCTS, LTD. PORTADOWN ROAD, LURGAN, CRAIGAVON, CO. Armagh Bt66 8rd, IE |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-21 |
| Decision Date | 1985-05-16 |