The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Ballard Medical Products Faciletome Bow String Papillotome.
| Device ID | K990376 |
| 510k Number | K990376 |
| Device Name: | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Contact | E. Martin Chamberlain |
| Correspondent | E. Martin Chamberlain BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-08 |
| Decision Date | 1999-05-03 |
| Summary: | summary |