The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles.
| Device ID | K081768 |
| 510k Number | K081768 |
| Device Name: | COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES |
| Classification | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Susanne Galin |
| Correspondent | Susanne Galin COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | NAJ |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-20 |
| Decision Date | 2008-12-23 |
| Summary: | summary |