Request – 510(k) Submission Records for Enspire 3000 (K230930, STERIS Corporation)

Request – 510(k) Submission Records for Enspire 3000 (K230930, STERIS Corporation)

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510(K) Number: K230930
Device Name: enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
Manufacturer: STERIS Corporation
Device Classification Name: Accessories, Cleaning, For Endoscope
Regulation Number: 876.1500
Classification Product Code: FEB
Date Received: 04/03/2023
Decision Date: 06/30/2023
Regulation Medical Specialty: Gastroenterology/Urology
Request Contents: Request for 510(k) submission records: K230930 (Enspire 3000 Cleaning and Liquid Chemical Sterile Processing System, STERIS Corporation).
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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