The following data is part of a premarket notification filed by Bionen S.a.s. with the FDA for Disposable And Reusable Concentric Needles / Disposable And Reusable Monopolar Needle.
| Device ID | K092973 |
| 510k Number | K092973 |
| Device Name: | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | BIONEN S.A.S. 11460 N. MERIDIAN ST., STE 150 Carmel, IN 46032 |
| Contact | Allison Scott |
| Correspondent | Allison Scott BIONEN S.A.S. 11460 N. MERIDIAN ST., STE 150 Carmel, IN 46032 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-25 |
| Decision Date | 2010-10-07 |
| Summary: | summary |