The following data is part of a premarket notification filed by New World Medical, Inc. with the FDA for Streamline Surgical System.
| Device ID | K211680 |
| 510k Number | K211680 |
| Device Name: | Streamline Surgical System |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | New World Medical, Inc. 10763 Edison Court Rancho Cucamonga, CA 91730 |
| Contact | Victor Arellano |
| Correspondent | Victor Arellano New World Medical, Inc. 10763 Edison Court Rancho Cucamonga, CA 91730 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2021-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00892064002010 | K211680 | 000 |
| 00892064002072 | K211680 | 000 |