EPICATH— 510(k) K862358

Substantially Equivalent

Hdc Corp.

FDA 510(k) clearance K862358 for EPICATH, Substantially Equivalent on 1986-07-07. Applicant: Hdc Corp.. Device class: 2.

Clearance details

Applicant
Hdc Corp.
Product code
Code KNE
Device class
Class 2
Regulation
21 CFR 884.5100
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mountain View, CA, US
Download summary PDFView on FDA.gov ↗

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