The following data is part of a premarket notification filed by Byron Medical with the FDA for Byron Word Bartholian Gland Catheter.
| Device ID | K861877 |
| 510k Number | K861877 |
| Device Name: | BYRON WORD BARTHOLIAN GLAND CATHETER |
| Classification | Catheter, Balloon Type |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Fred Chapel |
| Correspondent | Fred Chapel BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | GBA |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-15 |
| Decision Date | 1986-05-30 |