The following data is part of a premarket notification filed by Mini Lap Technologies Inc. with the FDA for Mini Lap Pediatric Instruments With Medusa Clamping System.
| Device ID | K070352 |
| 510k Number | K070352 |
| Device Name: | MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | MINI LAP TECHNOLOGIES INC. 543 LONG HILL AVE. Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary MINI LAP TECHNOLOGIES INC. 543 LONG HILL AVE. Shelton, CT 06484 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-06 |
| Decision Date | 2007-04-05 |
| Summary: | summary |