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510(k) K053412

FLEXISCOPE, MODELS 50MH AND 50 MHC by Schoelly Imaging, Inc. — Product Code FWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2006
Date Received
December 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K982965 — ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES (November 23, 1998)
  • K982397 — VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM (September 10, 1998)
  • K982409 — VES 1501-M (August 21, 1998)
  • K981819 — ANGIOLAZ VES-1CAM (August 4, 1998)
  • K944707 — ISOLATED CAMERA HEAD (October 7, 1994)
  • K930297 — FUJINON VIDEO LAPAROSCOPE, MODIFIED (March 29, 1994)
  • K934682 — SURGICAL VIDEO CAMERA AND ACCESSORIES (February 15, 1994)
  • K932628 — ENDOSCOPIC VIDEO CAMERA (October 15, 1993)