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510(k) K833297

BRONCHOSCOPY TUBE W/ULTRA LOCUFF by Surgitek — Product Code BTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
September 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Bronchial (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5720
Review Panel
AN
Submission Type

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Other clearances for product code BTS

  • K953963 — RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIA (November 27, 1995)
  • K951091 — RUSCH ENDOBRONCHIAL TUBE SETS (June 8, 1995)
  • K902116 — MODIFIED ENDOBRONCHIAL TUBE (August 3, 1990)
  • K834565 — ENDOBRONCHIAL TWIN LUMEN TUBE (January 17, 1984)
  • K771219 — BRONCHO-CATH (August 4, 1977)