The following data is part of a premarket notification filed by Lamidey Noury Medical with the FDA for Mcb Unit Model: V10gmcbus.
| Device ID | K222542 |
| 510k Number | K222542 |
| Device Name: | MCB UNIT Model: V10GMCBUS |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Lamidey Noury Medical 3 Rue Des Petits Ruisseaux Verriere Le Buisson, FR 91370 |
| Contact | M. Guillaume Noury |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-08-22 |
| Decision Date | 2022-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665415002116 | K222542 | 000 |