The following data is part of a premarket notification filed by Surgitek Medical Engineering Corp. with the FDA for Surgitek(r) Laparoscopic Cholangiogram Kit.
| Device ID | K913294 |
| 510k Number | K913294 |
| Device Name: | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | William H Duffell |
| Correspondent | William H Duffell SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-24 |
| Decision Date | 1991-10-04 |