The following data is part of a premarket notification filed by Meditron Devices, Inc. with the FDA for Arthoscope And Accessories.
Device ID | K931076 |
510k Number | K931076 |
Device Name: | ARTHOSCOPE AND ACCESSORIES |
Classification | Arthroscope |
Applicant | MEDITRON DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
Contact | Samuel Dickstein |
Correspondent | Samuel Dickstein MEDITRON DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-02 |
Decision Date | 1994-03-31 |