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510(k) K896008

MODEL 6500 MERCURY ARC LIGHT SOURCE by Medical Dynamics, Inc. — Product Code GCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1989
Date Received
October 13, 1989
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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  • K903339 — VIDEO ENDOSCOPE, RIGID (March 6, 1991)
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Other clearances for product code GCP

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  • K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE (February 12, 1986)
  • K843683 — MODULAR FIBERSCOPE SYSTEM (January 18, 1985)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K821999 — ENDOSCOPIC SCLEROTHERAPY BALLOON (August 27, 1982)
  • K801247 — CCD ENDOSCOPE AND ATTACHMENTS (July 28, 1980)
  • K790071 — ENDOSCOPE AND ACCESSORIES (April 2, 1979)
  • K771918 — FIBEO OPTICS ILLUM. SYSTEM (October 20, 1977)