The following data is part of a premarket notification filed by Dravon Medical, Inc. with the FDA for S-610 Shunt Adaptor Set.
| Device ID | K811851 |
| 510k Number | K811851 |
| Device Name: | S-610 SHUNT ADAPTOR SET |
| Classification | Adapter, A-v Shunt Or Fistula |
| Applicant | DRAVON MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNR |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-08-31 |