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510(k) K884039

MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 by Medical Dynamics, Inc. — Product Code FWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1988
Date Received
September 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Cine, Surgical, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

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  • K930568 — ADAIR/VERESS NEEDLE INTRODUCER SET (July 22, 1993)
  • K915538 — OVER THE WIRE STONE BASKET (March 20, 1992)
  • K914315 — OPTICAL CATHETER INTRODUCER SETS, MODIFICATION (March 4, 1992)
  • K913986 — CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM (January 28, 1992)
  • K911296 — OPTICAL CATHETER ARTHROSCOPE (September 24, 1991)
  • K903339 — VIDEO ENDOSCOPE, RIGID (March 6, 1991)
  • K904609 — XENON LIGHT SOURCE (December 18, 1990)

Other clearances for product code FWH

  • K823516 — ESA CAMERA (December 30, 1982)