The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Core And Coil Assembly Guidewire.
Device ID | K970994 |
510k Number | K970994 |
Device Name: | CORE AND COIL ASSEMBLY GUIDEWIRE |
Classification | Stylet For Catheter, Gastro-urology |
Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
Contact | Kim Aves |
Correspondent | Kim Aves LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
Product Code | EZB |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-19 |
Decision Date | 1997-03-25 |
Summary: | summary |