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510(k) K812305

MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE by Boston Medical Products, Inc. — Product Code KCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
August 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Esophageal, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

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  • 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 KCF

  • K962688 — MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE (July 25, 1996)
  • K923355 — PHARYNGEAL SALIVARY BYPASS TUBE (October 6, 1992)