The following data is part of a premarket notification filed by Concord/portex with the FDA for Subcutaneous Tunneling Needle And Handles.
| Device ID | K930218 |
| 510k Number | K930218 |
| Device Name: | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES |
| Classification | Catheter, Percutaneous, Intraspinal, Short Term |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | MAJ |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-15 |
| Decision Date | 1993-07-27 |