The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Laparoscopic Cholangiogram Catheter & Kit.
| Device ID | K914755 |
| 510k Number | K914755 |
| Device Name: | DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Annette Fagnant |
| Correspondent | Annette Fagnant DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-22 |
| Decision Date | 1992-03-30 |