K982688 is an FDA 510(k) clearance for the SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK. This device is classified as a Elastomer, Silicone Block (Class II - Special Controls, product code MIB).
Submitted by Spectrum Designs, Inc. (Carpineteria, US). The FDA issued a Cleared decision on October 13, 1998, 71 days after receiving the submission on August 3, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K982688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1998 |
| Decision Date | October 13, 1998 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MIB — Elastomer, Silicone Block |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |