The following data is part of a premarket notification filed by Mini Lap Technologies Inc. with the FDA for Mini Lap Retractors.
| Device ID | K093449 |
| 510k Number | K093449 |
| Device Name: | MINI LAP RETRACTORS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MINI LAP TECHNOLOGIES INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary MINI LAP TECHNOLOGIES INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-05 |
| Decision Date | 2010-02-12 |
| Summary: | summary |