PALPATION ENHANCER— 510(k) K801811

Substantially Equivalent

Medical Horizons Co.

FDA 510(k) clearance K801811 for PALPATION ENHANCER, Substantially Equivalent on 1980-09-09. Applicant: Medical Horizons Co.. Device class: 1.

Clearance details

Applicant: Medical Horizons Co.
Product code: Code LDE
Device class: Class 1
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 1980-07-08
Decision date: 1980-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.