The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for Wrist Traction.
Device ID | K926069 |
510k Number | K926069 |
Device Name: | WRIST TRACTION |
Classification | System, X-ray, Stationary |
Applicant | OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc., CA H4l 4z1 |
Contact | Jean A Vezina |
Correspondent | Jean A Vezina OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc., CA H4l 4z1 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-01 |
Decision Date | 1993-01-21 |