The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Encapsulated Guidewire With Flexible Tip.
| Device ID | K914358 |
| 510k Number | K914358 |
| Device Name: | ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Contact | Robert G Whalen |
| Correspondent | Robert G Whalen HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1991-11-19 |