The following data is part of a premarket notification filed by Stryker with the FDA for Inzone Detachment System.
| Device ID | K120816 |
| 510k Number | K120816 |
| Device Name: | INZONE DETACHMENT SYSTEM |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Stryker 47900 BAYSIDE PARKWAY Fremont, CA 94538 |
| Contact | Mara Chou |
| Correspondent | Mara Chou Stryker 47900 BAYSIDE PARKWAY Fremont, CA 94538 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540697950 | K120816 | 000 |