The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Freeway And Railrunner Guidewires.
Device ID | K082922 |
510k Number | K082922 |
Device Name: | FREEWAY AND RAILRUNNER GUIDEWIRES |
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 | 2008-10-01 |
Decision Date | 2008-12-09 |
Summary: | summary |