The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Telegraph Humeral Nail.
Device ID | K023241 |
510k Number | K023241 |
Device Name: | TELEGRAPH HUMERAL NAIL |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | FOURNITURES HOSPITALIERES INDUSTRIE 6258 SHADY GROVE RD. EAST Memphis, TN 38120 |
Contact | M. Frank Lewis |
Correspondent | M. Frank Lewis FOURNITURES HOSPITALIERES INDUSTRIE 6258 SHADY GROVE RD. EAST Memphis, TN 38120 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-30 |
Decision Date | 2002-12-24 |
Summary: | summary |