The following data is part of a premarket notification filed by Bard Interventional Products Div. with the FDA for Bard High Flow Papillotome.
| Device ID | K963484 |
| 510k Number | K963484 |
| Device Name: | BARD HIGH FLOW PAPILLOTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | BARD INTERVENTIONAL PRODUCTS DIV. 129 CONCORD RD. P.O. BOX 7031 Billerica, MA 01821 -7031 |
| Contact | Beth A Rochette, R.a.c. |
| Correspondent | Beth A Rochette, R.a.c. BARD INTERVENTIONAL PRODUCTS DIV. 129 CONCORD RD. P.O. BOX 7031 Billerica, MA 01821 -7031 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-11-19 |
| Summary: | summary |