FDA 510(k), K142427, TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25

FDA 510(k), K142427, TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25

Regular price $49.00 USD
Regular price Sale price $49.00 USD
Sale Sold out
510(K) Number: K142427
Device Name: TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25
Manufacturer: AEREE LEE
Device Classification Name: Laparoscope, General & Plastic Surgery
Regulation Number: GCJ
Classification Product Code: KXA
Date Received: 08/29/2014
Decision Date: 12/23/2014
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.

View full details