INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT— 510(k) K823108

Name: FDA 510(k) clearance K823108
Creator: U.S. Food and Drug Administration
Published: 1982-11-30

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K823108 for INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT, Substantially Equivalent on 1982-11-30. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1982-10-21
Decision date: 1982-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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