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 |