The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Duralastic Ii.
| Device ID | K955370 |
| 510k Number | K955370 |
| Device Name: | DURALASTIC II |
| Classification | Elastomer, Silicone Block |
| Applicant | ALLIED BIOMEDICAL CORP. 118-D SPRINGHALL DR. Goose Creek, SC 29445 |
| Contact | Gerald Hanson |
| Correspondent | Gerald Hanson ALLIED BIOMEDICAL CORP. 118-D SPRINGHALL DR. Goose Creek, SC 29445 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-22 |
| Decision Date | 1996-02-08 |