The following data is part of a premarket notification filed by Baxter Healthcare Corportation with the FDA for Easygrip Flo-41 Precision Mis Delivery System.
| Device ID | K193137 |
| 510k Number | K193137 |
| Device Name: | EASYGRIP FLO-41 Precision MIS Delivery System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Baxter Healthcare Corportation 32650 N. Wilson Road Round Lake, IL 60073 |
| Contact | Jeanette Licata |
| Correspondent | Jeanette Licata Baxter Healthcare Corportation 32650 N. Wilson Road Round Lake, IL 60073 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-13 |
| Decision Date | 2020-01-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55413765586113 | K193137 | 000 |