HR-5000 ELECTROSURGICAL DEVICE— 510(k) K864869

Substantially Equivalent

Ime Co. , Ltd.

FDA 510(k) clearance K864869 for HR-5000 ELECTROSURGICAL DEVICE, Substantially Equivalent on 1987-05-19. 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: 1986-12-12
Decision date: 1987-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K943396 — THE ELITE SPECTRUM1994-09-16

More clearances from Ime Co. , Ltd.

K881276 — HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS1988-05-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.