The following data is part of a premarket notification filed by Acueity, Inc. with the FDA for Viaduct Microendoscope And Accessories.
| Device ID | K011189 |
| 510k Number | K011189 |
| Device Name: | VIADUCT MICROENDOSCOPE AND ACCESSORIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ACUEITY, INC. 15 INDUSTRIAL PARK EAST Oxford, MA 01540 |
| Contact | Marybeth Fecteau |
| Correspondent | Marybeth Fecteau ACUEITY, INC. 15 INDUSTRIAL PARK EAST Oxford, MA 01540 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-18 |
| Decision Date | 2001-07-16 |