OP-CON SURGICAL INSTRUMENTS #4— 510(k) K834174

Name: FDA 510(k) clearance K834174
Creator: U.S. Food and Drug Administration
Published: 1983-12-27

Substantially Equivalent

Imm Enterprises , Ltd.

FDA 510(k) clearance K834174 for OP-CON SURGICAL INSTRUMENTS #4, Substantially Equivalent on 1983-12-27. Applicant: Imm Enterprises , Ltd.. Device class: 2.

Clearance details

Applicant: Imm Enterprises , Ltd.
Product code: Code HCZ
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1983-11-21
Decision date: 1983-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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