The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Twist Drill.
Device ID | K062842 |
510k Number | K062842 |
Device Name: | TWIST DRILL |
Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Contact | Kim Reed |
Correspondent | Kim Reed WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Product Code | HBE |
CFR Regulation Number | 882.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-22 |
Decision Date | 2006-12-04 |
Summary: | summary |