PEM-T— 510(k) K830497

Substantially Equivalent

Hedeco

FDA 510(k) clearance K830497 for PEM-T, Substantially Equivalent on 1983-04-05. Applicant: Hedeco. Device class: 1.

Clearance details

Applicant: Hedeco
Product code: Code JWZ
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1983-02-16
Decision date: 1983-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.