IMPLANT AID SPLICING CRIMP & SLEEVE— 510(k) K813518

Name: FDA 510(k) clearance K813518
Creator: U.S. Food and Drug Administration
Published: 1982-01-12

Substantially Equivalent

Intermedics, Inc.

FDA 510(k) clearance K813518 for IMPLANT AID SPLICING CRIMP & SLEEVE, Substantially Equivalent on 1982-01-12. Applicant: Intermedics, Inc.. Device class: 3.

Clearance details

Applicant: Intermedics, Inc.
Product code: Code KFJ
Device class: Class 3
Regulation: 21 CFR 870.3710
Advisory panel: Cardiovascular
Date received: 1981-12-16
Decision date: 1982-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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