The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Burney Gallbladder Catheter Kit.
| Device ID | K880343 |
| 510k Number | K880343 |
| Device Name: | BURNEY GALLBLADDER CATHETER KIT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MALLINCKRODT CRITICAL CARE 675 MCDONNELL BLVD. P.O. BOX 5840 St Louis, MO 63134 |
| Contact | Robert S Lake |
| Correspondent | Robert S Lake MALLINCKRODT CRITICAL CARE 675 MCDONNELL BLVD. P.O. BOX 5840 St Louis, MO 63134 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1989-05-01 |