SPAND-GEL GRANULATED GEL— 510(k) K864124

Name: FDA 510(k) clearance K864124
Creator: U.S. Food and Drug Administration
Published: 1986-11-26

Substantially Equivalent for Some Indications

Medi-Tech Intl. Corp.

FDA 510(k) clearance K864124 for SPAND-GEL GRANULATED GEL, Substantially Equivalent for Some Indications on 1986-11-26. Applicant: Medi-Tech Intl. Corp.. Device class: 1.

Clearance details

Applicant: Medi-Tech Intl. Corp.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1986-10-21
Decision date: 1986-11-26
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Brooklyn, NY, 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.