The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Mandrel Guidewire Assembly.
| Device ID | K011084 |
| 510k Number | K011084 |
| Device Name: | MANDREL GUIDEWIRE ASSEMBLY |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jim Klosterman |
| Correspondent | Jim Klosterman 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 | 2001-04-10 |
| Decision Date | 2001-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902101489 | K011084 | 000 |
| 20801902207146 | K011084 | 000 |
| 20801902193432 | K011084 | 000 |
| 20801902013204 | K011084 | 000 |
| 20801902101482 | K011084 | 000 |
| 20801902095859 | K011084 | 000 |
| 10801902013214 | K011084 | 000 |
| 30801902013195 | K011084 | 000 |
| 30801902013201 | K011084 | 000 |
| 30801902013218 | K011084 | 000 |
| 30801902101465 | K011084 | 000 |
| 30801902101472 | K011084 | 000 |
| 20801902213864 | K011084 | 000 |