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510(k) K897049

GIBSON ENDOLYMPHATIC SHUNT by Hood Laboratories — Product Code ESZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1990
Date Received
December 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Shunt, Endolymphatic
Device Class
Class II
Regulation Number
874.3820
Review Panel
EN
Submission Type

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  • K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT (January 14, 1991)
  • K897059 — HOOD SPEAKING VALVE (March 12, 1990)
  • K893866 — HOOD PEDIATRIC TRACHEOSTOMY TUBE (August 7, 1989)
  • K884810 — SILICONE LARYNGEAL STENT (May 10, 1989)
  • K890599 — HOOD NASAL SPLINT (March 17, 1989)
  • K885125 — KRUPIN EYE VALVE W/SCLERAL BUCKLE (January 24, 1989)
  • K882430 — HOOD TRACHEAL STOMA BUTTON (June 28, 1988)

Other clearances for product code ESZ

  • K974224 — ENDOLYMPHATIC SAC TO MASTOID T-SHUNT (January 27, 1998)
  • K952227 — C-FLEX ENDOLYMPHATIC SHUNT (June 16, 1995)
  • K834094 — AUSTIN ENDOLYMPH DISPERSMENT SHUNT (September 20, 1984)