The following data is part of a premarket notification filed by Maquet Cardiovascular, Llc with the FDA for 7 Mm Extended Length Endoscope.
| Device ID | K191930 |
| 510k Number | K191930 |
| Device Name: | 7 Mm Extended Length Endoscope |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Maquet Cardiovascular, LLC 45 Barbour Pond Drive Wayne, NJ 07470 |
| Contact | Mark Dinger |
| Correspondent | Mark Dinger Maquet Cardiovascular, LLC 45 Barbour Pond Drive Wayne, NJ 07470 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-19 |
| Decision Date | 2020-04-15 |