OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA— 510(k) K981993

Substantially Equivalent

The Olympus Optical Co.

FDA 510(k) clearance K981993 for OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA, Substantially Equivalent on 1998-08-21. Applicant: The Olympus Optical Co.. Device class: 2.

Clearance details

Applicant
The Olympus Optical Co.
Product code
Code ODA
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Melville, NY, US
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