The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Efer Arthroscope.
Device ID | K870654 |
510k Number | K870654 |
Device Name: | EFER ARTHROSCOPE |
Classification | Arthroscope |
Applicant | ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
Contact | Darienne Moyer |
Correspondent | Darienne Moyer ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-13 |
Decision Date | 1987-05-14 |