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510(k) K812305

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

K812305 is an FDA 510(k) premarket notification submitted by Boston Medical Products, Inc. for the device "MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code KCF (Dilator, Esophageal, Ent), a Class I device regulated under 21 CFR 874.4420. Boston Medical Products, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Boston Medical Products, Inc.

  • K091135 — RUTTER SUPRA STOMAL STENTS (September 14, 2009)
  • 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)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K972082 — CUSTOM NASAL SPLINT (July 3, 1997)
  • K972077 — EPI-STOP 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)

FDA data resources