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510(k) K802915

MONTG. TRACHEAL TREPHINE FENE STRATOR by Boston Medical Products, Inc. — Product Code KBF

K802915 is an FDA 510(k) premarket notification submitted by Boston Medical Products, Inc. for the device "MONTG. TRACHEAL TREPHINE FENE STRATOR". The FDA issued a decision of Substantially Equivalent on December 19, 1980. The device falls under product code KBF (Trephine, Sinus), 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
December 19, 1980
Date Received
November 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trephine, Sinus
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)
  • K972076 — EPI-MAX EPISTAXIS CATHETER (June 26, 1997)

FDA data resources