The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Taxi Endoscopic Guidewire.
| Device ID | K081708 |
| 510k Number | K081708 |
| Device Name: | TAXI ENDOSCOPIC GUIDEWIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Deep Pal |
| Correspondent | Deep Pal LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-08-26 |
| Summary: | summary |