The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Spectrum Designs Silicone Block.
| Device ID | K960038 |
| 510k Number | K960038 |
| Device Name: | SPECTRUM DESIGNS SILICONE BLOCK |
| Classification | Elastomer, Silicone Block |
| Applicant | SPECTRUM DESIGNS, INC. 5921 MATTHEWS ST. UNIT C Goleta, CA 93117 |
| Contact | Jim Dishman |
| Correspondent | Jim Dishman SPECTRUM DESIGNS, INC. 5921 MATTHEWS ST. UNIT C Goleta, CA 93117 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-03 |
| Decision Date | 1996-03-13 |