The following data is part of a premarket notification filed by Wiltek Medical, Inc. with the FDA for Wiltek Balloon Stone Extractor.
| Device ID | K894865 |
| 510k Number | K894865 |
| Device Name: | WILTEK BALLOON STONE EXTRACTOR |
| Classification | Dislodger, Stone, Biliary |
| Applicant | WILTEK MEDICAL, INC. P.O.BOX 11946 Winston-salem, NC 27116 |
| Contact | Jon S Wilson |
| Correspondent | Jon S Wilson WILTEK MEDICAL, INC. P.O.BOX 11946 Winston-salem, NC 27116 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-31 |
| Decision Date | 1989-12-21 |