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510(k) K941715

ULTATHIN FLEXIBLE ENDOSCOPE by Technology Marketing Group — Product Code LYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1994
Date Received
April 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Angioscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
CV
Submission Type

Other clearances by Technology Marketing Group

  • K942388 — TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE (August 17, 1994)
  • K935834 — TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE (March 7, 1994)

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  • K952638 — 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE (July 28, 1995)
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