The following data is part of a premarket notification filed by Protein Polymer Technologies, Inc. with the FDA for Modified Pva-plus Foam Embolization Particles And Maxistat And Microstat Pva Foam Embolization Particles.
| Device ID | K053548 |
| 510k Number | K053548 |
| Device Name: | MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES |
| Classification | Device, Neurovascular Embolization |
| Applicant | PROTEIN POLYMER TECHNOLOGIES, INC. 10655 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Contact | R. Stephen Reitzler |
| Correspondent | R. Stephen Reitzler PROTEIN POLYMER TECHNOLOGIES, INC. 10655 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-20 |
| Decision Date | 2006-01-30 |
| Summary: | summary |