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 |