The following data is part of a premarket notification filed by Surgitek Medical Engineering Corp. with the FDA for Surgitek(r) 420 Cm G.i. Infusion Guidewire.
| Device ID | K910768 |
| 510k Number | K910768 |
| Device Name: | SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Steve Aperavich |
| Correspondent | Steve Aperavich 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 | 1991-02-22 |
| Decision Date | 1991-03-19 |