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FDA 510(k), K853585, OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
FDA 510(k), K853585, OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
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510(K) Number: K853585
Device Name: OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
Manufacturer: TERRY J HARTL
Device Classification Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation Number: FET
Classification Product Code: KXA
Date Received: 08/26/1985
Decision Date: 01/21/1986
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
Manufacturer: TERRY J HARTL
Device Classification Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation Number: FET
Classification Product Code: KXA
Date Received: 08/26/1985
Decision Date: 01/21/1986
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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