The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Microplex Coil System-cosmos.
| Device ID | K090891 |
| 510k Number | K090891 |
| Device Name: | MICROPLEX COIL SYSTEM-COSMOS |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170014185 | K090891 | 000 |
| 00810170014116 | K090891 | 000 |