The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Laborie Injetak Adjustable Tip Needle, Flexible Tip And Ridgid Tip.
| Device ID | K090830 |
| 510k Number | K090830 |
| Device Name: | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 400 AVENUE D SUITE 10 Williston, VT 05495 |
| Contact | Barbara Mornet |
| Correspondent | Barbara Mornet LABORIE MEDICAL TECHNOLOGIES, LTD. 400 AVENUE D SUITE 10 Williston, VT 05495 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-26 |
| Decision Date | 2009-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20627825000028 | K090830 | 000 |
| 20627825000011 | K090830 | 000 |