The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Triple Lumen Balloon Stone Extractor.
| Device ID | K953951 |
| 510k Number | K953951 |
| Device Name: | WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Paula Joyce |
| Correspondent | Paula Joyce WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002268579 | K953951 | 000 |
| 00827002225350 | K953951 | 000 |
| 00827002225343 | K953951 | 000 |
| 00827002225336 | K953951 | 000 |
| 00827002225329 | K953951 | 000 |
| 00827002225312 | K953951 | 000 |
| 00827002225305 | K953951 | 000 |
| 00827002222625 | K953951 | 000 |
| 00827002216648 | K953951 | 000 |
| 00827002251649 | K953951 | 000 |
| 00827002251656 | K953951 | 000 |
| 00827002268562 | K953951 | 000 |
| 00827002268449 | K953951 | 000 |
| 00827002268401 | K953951 | 000 |
| 00827002256200 | K953951 | 000 |
| 00827002251694 | K953951 | 000 |
| 00827002251687 | K953951 | 000 |
| 00827002251670 | K953951 | 000 |
| 00827002251663 | K953951 | 000 |
| 00827002216037 | K953951 | 000 |