The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Modification To Self-drilling Radiographic Markers.
Device ID | K040990 |
510k Number | K040990 |
Device Name: | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS |
Classification | Marker, Radiographic, Implantable |
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 | NEU |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-16 |
Decision Date | 2004-05-13 |
Summary: | summary |