The following data is part of a premarket notification filed by Minilap Technologies with the FDA for Mini-lap Bipolar Electrocautery Devices.
| Device ID | K113597 |
| 510k Number | K113597 |
| Device Name: | MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MINILAP TECHNOLOGIES 88 ASHFORD AVE Dobbs Ferry, NY 10522 |
| Contact | Allan Alward |
| Correspondent | Allan Alward MINILAP TECHNOLOGIES 88 ASHFORD AVE Dobbs Ferry, NY 10522 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-05 |
| Decision Date | 2012-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704582635 | K113597 | 000 |
| 34026704738008 | K113597 | 000 |
| 24026704738018 | K113597 | 000 |
| 34026704640097 | K113597 | 000 |
| 24026704640106 | K113597 | 000 |
| 24026704640113 | K113597 | 000 |
| 24026704645309 | K113597 | 000 |
| 24026704582611 | K113597 | 000 |
| 24026704582628 | K113597 | 000 |
| 24026704737998 | K113597 | 000 |