The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Spectrum Designs Spectragel.
| Device ID | K970702 |
| 510k Number | K970702 |
| Device Name: | SPECTRUM DESIGNS SPECTRAGEL |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | SPECTRUM DESIGNS, INC. 5921 C. MATTHEWS ST. Goleta, CA 93117 |
| Contact | Jim Dishman |
| Correspondent | Jim Dishman SPECTRUM DESIGNS, INC. 5921 C. MATTHEWS ST. Goleta, CA 93117 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-26 |
| Decision Date | 1997-05-12 |