The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for Octostop(r) Chair (new Model.
Device ID | K935444 |
510k Number | K935444 |
Device Name: | OCTOSTOP(R) CHAIR (NEW MODEL |
Classification | Table, Radiographic, Tilting |
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 | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-12 |
Decision Date | 1994-09-02 |