The following data is part of a premarket notification filed by Byron Medical with the FDA for Newman Cannulae System (ncs).
| Device ID | K862936 |
| 510k Number | K862936 |
| Device Name: | NEWMAN CANNULAE SYSTEM (NCS) |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Byron Economidy |
| Correspondent | Byron Economidy BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-04 |
| Decision Date | 1986-08-14 |