FDA 510(k), K141057, DISPOSABLE CERVICAL BRUSH

FDA 510(k), K141057, DISPOSABLE CERVICAL BRUSH

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510(K) Number: K141057
Device Name: DISPOSABLE CERVICAL BRUSH
Manufacturer: NINGBO HLS MEDICAL PRODUCTS CO., LTD
Device Classification Name: spatula, cervical, cytological
Regulation Number: 884.4530
Classification Product Code: HHT
Date Received: 04/24/2014
Decision Date: 05/14/2015
Regulation Medical Specialty: Obstetrics/Gynecology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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