The following data is part of a premarket notification filed by Riskontrol with the FDA for Riskontrol Single Use.
| Device ID | K923876 |
| 510k Number | K923876 |
| Device Name: | RISKONTROL SINGLE USE |
| Classification | Unit, Syringe, Air And/or Water |
| Applicant | RISKONTROL 524 EAST CORONADO RD. Santa Fe, NM 87501 |
| Contact | Erick F Carlgren |
| Correspondent | Erick F Carlgren RISKONTROL 524 EAST CORONADO RD. Santa Fe, NM 87501 |
| Product Code | ECB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-03 |
| Decision Date | 1993-04-05 |