FOLEY-TEMP(TM)— 510(k) K882130

Substantially Equivalent

Mallinckroot, Inc.

FDA 510(k) clearance K882130 for FOLEY-TEMP(TM), Substantially Equivalent on 1988-08-09. Applicant: Mallinckroot, Inc.. Device class: 2.

Clearance details

Applicant: Mallinckroot, Inc.
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1988-05-20
Decision date: 1988-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Argyle, 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.