The following data is part of a premarket notification filed by Surgitek Medical Engineering Corp. with the FDA for E.r.c.p. Catheter.
| Device ID | K914495 |
| 510k Number | K914495 |
| Device Name: | E.R.C.P. CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-08 |
| Decision Date | 1992-01-30 |