The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Bioteq Double Pigtail Ureteral Stent Set.
| Device ID | K033210 |
| 510k Number | K033210 |
| Device Name: | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET |
| Classification | Stent, Ureteral |
| Applicant | BIOTEQUE CORP. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich BIOTEQUE CORP. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-03 |
| Decision Date | 2004-12-30 |
| Summary: | summary |