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510(k) K935834

TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE by Technology Marketing Group — Product Code FBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
December 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Choledochoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Technology Marketing Group

  • K941715 — ULTATHIN FLEXIBLE ENDOSCOPE (October 4, 1994)
  • K942388 — TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE (August 17, 1994)

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