The following data is part of a premarket notification filed by Applied Biomaterial Technologies with the FDA for Duralastic Sheeting.
| Device ID | K945552 |
| 510k Number | K945552 |
| Device Name: | DURALASTIC SHEETING |
| Classification | Elastomer, Silicone Block |
| Applicant | APPLIED BIOMATERIAL TECHNOLOGIES 9576 RIDGETOP BLVD. SILVERDALE, WA 98383 |
| Contact | GERALD HANSON |
| Correspondent | GERALD HANSON APPLIED BIOMATERIAL TECHNOLOGIES 9576 RIDGETOP BLVD. SILVERDALE, WA 98383 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-10 |
| Decision Date | 1995-01-31 |