The following data is part of a premarket notification filed by Te Me Na Sas with the FDA for Hybrid Nerve Location Needle Coated And Uncoated.
| Device ID | K080603 |
| 510k Number | K080603 |
| Device Name: | HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | TE ME NA SAS 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward TE ME NA SAS 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-08-05 |
| Summary: | summary |