The following data is part of a premarket notification filed by Micro Invasive Technology Inc. with the FDA for Directview, Lightguide, Model(s) 10rll-320 Laparoscope, 10dlg-320 Disposable Light Guide For Above.
| Device ID | K072613 |
| 510k Number | K072613 |
| Device Name: | DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICRO INVASIVE TECHNOLOGY INC. 934 NORTH MAIN ST Danielson, CT 06239 |
| Contact | John Bala |
| Correspondent | John Bala MICRO INVASIVE TECHNOLOGY INC. 934 NORTH MAIN ST Danielson, CT 06239 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2008-04-21 |
| Summary: | summary |