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510(k) K790071

ENDOSCOPE AND ACCESSORIES by Olympus Corp. — Product Code GCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1979
Date Received
January 11, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Ac-Powered And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K821999 — ENDOSCOPIC SCLEROTHERAPY BALLOON (August 27, 1982)
  • K801247 — CCD ENDOSCOPE AND ATTACHMENTS (July 28, 1980)
  • K771918 — FIBEO OPTICS ILLUM. SYSTEM (October 20, 1977)