The following data is part of a premarket notification filed by Sedatelec with the FDA for Sedatelec Asp Acupuncture Needles.
| Device ID | K983798 |
| 510k Number | K983798 |
| Device Name: | SEDATELEC ASP ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | SEDATELEC 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf SEDATELEC 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-28 |
| Decision Date | 1999-08-27 |
| Summary: | summary |