← Product Code [MDA](/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA) · K970702

# SPECTRUM DESIGNS SPECTRAGEL (K970702)

_Spectrum Designs, Inc. · MDA · May 12, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K970702

## Device Facts

- **Applicant:** Spectrum Designs, Inc.
- **Product Code:** [MDA](/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA.md)
- **Decision Date:** May 12, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4025
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K970702](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K970702)

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