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510(k) K190744

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) by Olympus Winter & Ibe GmbH — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2019
Date Received
March 22, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

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