The following data is part of a premarket notification filed by Emed Technologies Corporation with the FDA for Accusert Needle Inserter.
| Device ID | K213429 |
| 510k Number | K213429 |
| Device Name: | AccuSert Needle Inserter |
| Classification | Introducer, Syringe Needle |
| Applicant | Emed Technologies Corporation 1262 Hawks Flight Ct, Ste. 200 El Dorado Hills, CA 95762 |
| Contact | Peter Kollings |
| Correspondent | Olena Whalen Emed Technologies Corporation 1262 Hawks Flight Ct, Ste. 200 El Dorado Hills, CA 95762 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-21 |
| Decision Date | 2022-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817708022988 | K213429 | 000 |
| 00817708022964 | K213429 | 000 |