The following data is part of a premarket notification filed by Emcision, Ltd. with the FDA for Habib 4x.
| Device ID | K051420 |
| 510k Number | K051420 |
| Device Name: | HABIB 4X |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EMCISION, LTD. DU CANE ROAD London, GB W12 0hs |
| Contact | Nagy Habib |
| Correspondent | Chantel Carson UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2005-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H7874401S1 | K051420 | 000 |
| H7874401L1 | K051420 | 000 |
| H78744011 | K051420 | 000 |
| H7877001018920 | K051420 | 000 |