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510(k) K923355

PHARYNGEAL SALIVARY BYPASS TUBE by Boston Medical Products, Inc. — Product Code KCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1992
Date Received
July 8, 1992
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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  • 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)
  • K812305 — MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE (September 8, 1981)