The following data is part of a premarket notification filed by Minimally Invasive Devices, Inc. with the FDA for Floshield 10mm Endoscopic Cannula And Conical Blunt Obturator, Floshield 10mm Endoscopic Cannula, Floshield 10mm Conical Blunt Obturator.
| Device ID | K150705 |
| 510k Number | K150705 |
| Device Name: | FloShield 10mm Endoscopic Cannula And Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Minimally Invasive Devices, Inc. 1275 Kinnear Ave Columbus, OH 43026 |
| Contact | Trudie L Seeger |
| Correspondent | Trudie L Seeger Minimally Invasive Devices, Inc. 1275 Kinnear Ave Columbus, OH 43026 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-18 |
| Decision Date | 2015-04-13 |
| Summary: | summary |