510(k) Submission Request – PROTECTED BRONCHOALVEOLAR Lavage Balloon Catheter (K910536, Mill-Rose Laboratory)

510(k) Submission Request – PROTECTED BRONCHOALVEOLAR Lavage Balloon Catheter (K910536, Mill-Rose Laboratory)

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510(K) Number: K910536
Device Name: PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER
Manufacturer: MILL-ROSE LABORATORY
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 02/08/1991
Decision Date: 09/24/1991
Regulation Medical Specialty: Ear Nose & Throat
Request Contents: 510(k) Submission Request: Seeking the 510(k) submission for K910536. Device Classification Name: Bronchoscope (flexible or rigid) Device Name: PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER Applicant: MILL-ROSE LABORATORY
  • 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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