The following data is part of a premarket notification filed by Mini Lap Technologies Inc. with the FDA for Mini Lap Electrocautery Instruments.
| Device ID | K083754 |
| 510k Number | K083754 |
| Device Name: | MINI LAP ELECTROCAUTERY INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MINI LAP TECHNOLOGIES INC. 80 SHELTON TECHNOLOGY CTR. Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary MINI LAP TECHNOLOGIES INC. 80 SHELTON TECHNOLOGY CTR. Shelton, CT 06484 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-17 |
| Decision Date | 2009-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704582677 | K083754 | 000 |
| 34026704742678 | K083754 | 000 |
| 24026704742640 | K083754 | 000 |
| 24026704742657 | K083754 | 000 |
| 24026704640021 | K083754 | 000 |
| 24026704640052 | K083754 | 000 |
| 24026704640038 | K083754 | 000 |
| 34026704640042 | K083754 | 000 |
| 44026704582646 | K083754 | 000 |
| 44026704582653 | K083754 | 000 |
| 44026704582660 | K083754 | 000 |
| 34026704742661 | K083754 | 000 |