SPENCO SILICONE GEL SHEET— 510(k) K981902

Substantially Equivalent

Spenco Medical Corp.

FDA 510(k) clearance K981902 for SPENCO SILICONE GEL SHEET, Substantially Equivalent on 1998-06-25. Applicant: Spenco Medical Corp.. Device class: 1.

Clearance details

Applicant: Spenco Medical Corp.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1998-06-01
Decision date: 1998-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waco, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.