GELSKIN— 510(k) K791162

Substantially Equivalent

Spenco Medical Corp.

FDA 510(k) clearance K791162 for GELSKIN, Substantially Equivalent on 1979-09-04. Applicant: Spenco Medical Corp.. Device class: 2.

Clearance details

Applicant: Spenco Medical Corp.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1979-06-25
Decision date: 1979-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Spenco Medical Corp.

K981902 — SPENCO SILICONE GEL SHEET1998-06-25
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K910927 — SPENCIO SKIN GUARD KIT1991-06-03
K896533 — SPENCO BREAST FORMS1989-12-13

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