SPECTRUM DESIGNS SPECTRAGEL— 510(k) K992522

Name: FDA 510(k) clearance K992522
Creator: U.S. Food and Drug Administration
Published: 1999-10-26

Substantially Equivalent

Spectrum Designs, Inc.

FDA 510(k) clearance K992522 for SPECTRUM DESIGNS SPECTRAGEL, Substantially Equivalent on 1999-10-26. Applicant: Spectrum Designs, Inc.. Device class: 1.

Clearance details

Applicant: Spectrum Designs, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1999-07-28
Decision date: 1999-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpineteria, CA, US

Download summary PDF View on FDA.gov ↗

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