The following data is part of a premarket notification filed by Sedatelec with the FDA for Asp Titanium.
| Device ID | K060392 |
| 510k Number | K060392 |
| Device Name: | ASP TITANIUM |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | SEDATELEC 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SEDATELEC 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-15 |
| Decision Date | 2006-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760262490564 | K060392 | 000 |
| 03760262490465 | K060392 | 000 |
| 03760262490427 | K060392 | 000 |