The following data is part of a premarket notification filed by Robert Reid Inc. with the FDA for Magnum Nail.
Device ID | K093089 |
510k Number | K093089 |
Device Name: | MAGNUM NAIL |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ROBERT REID INC. 8202 SHERMAN RD Chesterland, OH 44026 -2141 |
Contact | Karen Warden |
Correspondent | Karen Warden ROBERT REID INC. 8202 SHERMAN RD Chesterland, OH 44026 -2141 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-01 |
Decision Date | 2009-11-13 |
Summary: | summary |