The following data is part of a premarket notification filed by Mectra Labs, Inc. with the FDA for Electro-lube.
| Device ID | K033880 |
| 510k Number | K033880 |
| Device Name: | ELECTRO-LUBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424 |
| Contact | Charles E Allgood Jr. |
| Correspondent | Charles E Allgood Jr. MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-15 |
| Decision Date | 2004-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817984011151 | K033880 | 000 |
| 10817984011147 | K033880 | 000 |
| 20817984010222 | K033880 | 000 |
| 20817984010215 | K033880 | 000 |
| 10849771037870 | K033880 | 000 |
| 60849771050416 | K033880 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ELECTRO-LUBE 90072308 not registered Live/Pending |
Stephania Holdings Inc. 2020-07-24 |
![]() ELECTRO-LUBE 77819711 3849529 Dead/Cancelled |
Electrolube Green LLC 2009-09-03 |