MODEL SD-1 DISINTEGRATOR— 510(k) K802322

Name: FDA 510(k) clearance K802322
Creator: U.S. Food and Drug Administration
Published: 1980-11-10

Substantially Equivalent

Northgate Research, Inc.

FDA 510(k) clearance K802322 for MODEL SD-1 DISINTEGRATOR, Substantially Equivalent on 1980-11-10. Applicant: Northgate Research, Inc.. Device class: 2.

Clearance details

Applicant: Northgate Research, Inc.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1980-09-23
Decision date: 1980-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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