The following data is part of a premarket notification filed by North Coast Medi-tek with the FDA for Ptc-6 And Ptc-8 Percutaneous Cholangiography.
| Device ID | K870420 |
| 510k Number | K870420 |
| Device Name: | PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY |
| Classification | Catheter, Cholangiography |
| Applicant | NORTH COAST MEDI-TEK 8603 EAST AVE. Mentor, OH 44060 |
| Contact | Theresa Sokolowski |
| Correspondent | Theresa Sokolowski NORTH COAST MEDI-TEK 8603 EAST AVE. Mentor, OH 44060 |
| Product Code | GBZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-04-14 |