The following data is part of a premarket notification filed by Mini Lap Technologies Inc. with the FDA for Mini Lap Instruments.
| Device ID | K070686 |
| 510k Number | K070686 |
| Device Name: | MINI LAP INSTRUMENTS |
| 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 | 2007-03-12 |
| Decision Date | 2007-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704582592 | K070686 | 000 |
| 34026704737957 | K070686 | 000 |
| 34026704737964 | K070686 | 000 |
| 24026704737974 | K070686 | 000 |
| 34026704640011 | K070686 | 000 |
| 34026704640073 | K070686 | 000 |
| 34026704640004 | K070686 | 000 |
| 24026704640069 | K070686 | 000 |
| 24026704645316 | K070686 | 000 |
| 44026704582561 | K070686 | 000 |
| 24026704582574 | K070686 | 000 |
| 24026704582581 | K070686 | 000 |
| 24026704737943 | K070686 | 000 |