The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Mandrel Guidewires Or M-wires.
| Device ID | K080144 |
| 510k Number | K080144 |
| Device Name: | MANDREL GUIDEWIRES OR M-WIRES |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-22 |
| Decision Date | 2008-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902145097 | K080144 | 000 |
| 20801902145080 | K080144 | 000 |
| 20801902145073 | K080144 | 000 |
| 20801902145066 | K080144 | 000 |
| 20801902145059 | K080144 | 000 |