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510(k) K950337

KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL by KARL STORZ Endoscopy-America, Inc. — Product Code EQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1995
Date Received
January 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type

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  • K191357 — Flexible HD Cysto-Urethroscope System (September 18, 2019)
  • K182723 — Flexible HD Cysto-Urethroscope System (April 23, 2019)
  • K182186 — CMOS Video-Rhino-Laryngoscope System (March 22, 2019)
  • K183264 — Flex-THOR scope (January 18, 2019)
  • K182696 — Telepack X LED (November 20, 2018)

Other clearances for product code EQJ

  • K161514 — Precision Thin Reciprocating Blade, 0.010in. (January 17, 2017)
  • K041985 — XPS CURVED BUR (August 12, 2004)
  • K974232 — ESSENTIAL SHAVER SYSTEM (January 12, 1998)
  • K960853 — ACE SYSTEM (April 3, 1996)
  • K955704 — TREBAY MICRODEBRIDER SYSTEM (January 30, 1996)
  • K955294 — SOF - ABRASION BUR (December 22, 1995)
  • K954912 — TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (December 6, 1995)
  • K953370 — KARL STORZ ENT SHAVER (September 6, 1995)
  • K952609 — REDI DRILL DRILL SYSTEM (July 31, 1995)
  • K953096 — ESSENTIAL SHAVER SYSTEM (July 28, 1995)