The following data is part of a premarket notification filed by Ezsurgical with the FDA for A-lap Set (a-lap, Ezaxess, Trocar).
| Device ID | K082291 |
| 510k Number | K082291 |
| Device Name: | A-LAP SET (A-LAP, EZAXESS, TROCAR) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | EZSURGICAL 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls EZSURGICAL 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-11 |
| Decision Date | 2009-01-02 |
| Summary: | summary |