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510(k) K873742

HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES by Hood Laboratories — Product Code NWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1987
Date Received
September 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Preformed/Molded
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type

The device is intended to provide support to weakened or constricting airway walls.

Other clearances by Hood Laboratories

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  • K905703 — KRUPIN EYE VALVE WITH DISK (March 15, 1991)
  • K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT (January 14, 1991)
  • K897049 — GIBSON ENDOLYMPHATIC SHUNT (March 16, 1990)
  • 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)

Other clearances for product code NWA

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  • K213969 — VisionAir Patient-Specific Airway Stent (October 7, 2022)
  • K182743 — Patient-Specific Airway Stent (October 23, 2019)
  • K971509 — ENDOXANE (August 21, 1997)
  • K894380 — DUMON TRACHEOBRONCHIAL STENT (October 24, 1989)