HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS— 510(k) K881276

Name: FDA 510(k) clearance K881276
Creator: U.S. Food and Drug Administration
Published: 1988-05-04

Substantially Equivalent

Ime Co. , Ltd.

FDA 510(k) clearance K881276 for HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS, Substantially Equivalent on 1988-05-04. Applicant: Ime Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Ime Co. , Ltd.
Product code: Code KCW
Device class: Class 1
Regulation: 21 CFR 878.5350
Advisory panel: General, Plastic Surgery
Date received: 1988-03-25
Decision date: 1988-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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