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510(k) K931398

GM SWIVEL VIDEO (TM) IRRIGATOR by Gm Engineering, Inc. — Product Code KAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1993
Date Received
March 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Sinus
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

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  • K941660 — GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT (May 24, 1994)
  • K933962 — GM CONTINUOUS FLOW BIOPSY PROBE (February 25, 1994)
  • K934035 — GM MONOPOLAR/FRAZIER SUCTION PROBE (December 1, 1993)
  • K930611 — TRUE FLOW(TM) VALVE (December 1, 1993)

Other clearances for product code KAR

  • K131177 — SINUFLUSH LAVAGE SYSTEM (September 20, 2013)
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