FDA 510(k), K200228, ClearCam System

FDA 510(k), K200228, ClearCam System

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510(K) Number: K200228
Device Name: ClearCam System
Manufacturer: Chris Idelson
Device Classification Name: Laparoscope, General & Plastic Surgery
Regulation Number: GCJ
Classification Product Code: KXA
Date Received: 01/30/2020
Decision Date: 02/19/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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