The following data is part of a premarket notification filed by Coburn Optical Ind., Inc. with the FDA for Magnilink System 402/5.
Device ID | K892350 |
510k Number | K892350 |
Device Name: | MAGNILINK SYSTEM 402/5 |
Classification | System, Reading, Television, Closed-circuit |
Applicant | COBURN OPTICAL IND., INC. 4606 S. GARNETT RD. SUITE 200 Tulsa, OK 74146 |
Contact | De Long |
Correspondent | De Long COBURN OPTICAL IND., INC. 4606 S. GARNETT RD. SUITE 200 Tulsa, OK 74146 |
Product Code | HJG |
CFR Regulation Number | 886.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-05 |
Decision Date | 1989-05-26 |