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510(k) K962693

MONTGOMERY RADIOPAQUE LARYNGEAL KEEL by Boston Medical Products, Inc. — Product Code FWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1996
Date Received
July 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Larynx (Stents And Keels)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

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  • K972317 — MONTGOMERY THYROPLASTY IMPLANT SYSTEM (September 18, 1997)
  • K972459 — RHINOCELL NASAL PACKINGS (August 4, 1997)
  • K972096 — BIVALVE NASAL SPLINT (July 15, 1997)
  • K972078 — POST-STOP EPISTAXIS CATHETER (July 10, 1997)
  • K972092 — NASAL AIRWAY SPLINT (July 8, 1997)
  • K972151 — DOYLE COMBO NASAL AIRWAY SPLINT (July 7, 1997)
  • K972082 — CUSTOM NASAL SPLINT (July 3, 1997)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K972076 — EPI-MAX EPISTAXIS CATHETER (June 26, 1997)

Other clearances for product code FWN

  • K091135 — RUTTER SUPRA STOMAL STENTS (September 14, 2009)
  • K000154 — ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 (March 29, 2000)
  • K896667 — LORENZ STENT (February 22, 1990)
  • K884810 — SILICONE LARYNGEAL STENT (May 10, 1989)
  • K864936 — 'EXMOOR' DAS GUPTA LARYNGEAL KEEL (April 27, 1987)
  • K853726 — LARYNGEAL (March 12, 1986)
  • K842800 — MONTG. LARYNGEAL KEEL (August 2, 1984)
  • K842287 — MONTGOMERY LARYNGEAL STENT (June 27, 1984)
  • K841347 — LARYNGEAL STENT (May 2, 1984)