The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Vinyl Silicone Elastomer Material.
| Device ID | K901990 |
| 510k Number | K901990 |
| Device Name: | VINYL SILICONE ELASTOMER MATERIAL |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights, NY 10598 |
| Contact | Laurence Colin |
| Correspondent | Laurence Colin CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights, NY 10598 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-02 |
| Decision Date | 1990-09-14 |