The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Cols Peek.
Device ID | K113591 |
510k Number | K113591 |
Device Name: | COLS PEEK |
Classification | Screw, Fixation, Bone |
Applicant | FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
Contact | Patricia Donnard |
Correspondent | Patricia Donnard FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-05 |
Decision Date | 2011-12-22 |
Summary: | summary |