The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Modification To Telegraph Humeral Nail.
Device ID | K033510 |
510k Number | K033510 |
Device Name: | MODIFICATION TO TELEGRAPH HUMERAL NAIL |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
Contact | Christine Quendez |
Correspondent | Christine Quendez FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-06 |
Decision Date | 2003-12-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03661489469268 | K033510 | 000 |
03661489460876 | K033510 | 000 |
03661489460869 | K033510 | 000 |
03661489460852 | K033510 | 000 |
03661489460845 | K033510 | 000 |
03661489500190 | K033510 | 000 |
03661489500183 | K033510 | 000 |
03661489500176 | K033510 | 000 |
03661489500169 | K033510 | 000 |
03661489500145 | K033510 | 000 |
03661489500138 | K033510 | 000 |
03661489500114 | K033510 | 000 |
03661489481130 | K033510 | 000 |
03661489481123 | K033510 | 000 |
03661489481116 | K033510 | 000 |
03661489460883 | K033510 | 000 |
03661489460890 | K033510 | 000 |
03661489469251 | K033510 | 000 |
03661489469244 | K033510 | 000 |
03661489461019 | K033510 | 000 |
03661489461002 | K033510 | 000 |
03661489460999 | K033510 | 000 |
03661489460982 | K033510 | 000 |
03661489460975 | K033510 | 000 |
03661489460968 | K033510 | 000 |
03661489460951 | K033510 | 000 |
03661489460944 | K033510 | 000 |
03661489460937 | K033510 | 000 |
03661489460920 | K033510 | 000 |
03661489460913 | K033510 | 000 |
03661489460906 | K033510 | 000 |
03661489481109 | K033510 | 000 |