The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Ercp Catheter, Hydrophilic Coated.
| Device ID | K932205 |
| 510k Number | K932205 |
| Device Name: | ERCP CATHETER, HYDROPHILIC COATED |
| Classification | Catheter, Irrigation |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Contact | Paula Joyce |
| Correspondent | Paula Joyce WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-06 |
| Decision Date | 1994-01-03 |