The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Linden Stone Extraction Balloon.
| Device ID | K872509 |
| 510k Number | K872509 |
| Device Name: | LINDEN STONE EXTRACTION BALLOON |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| 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 | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-24 |
| Decision Date | 1987-09-22 |