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510(k) K922902

SALMAN SINUS BUTTON by Boston Medical Products, Inc. — Product Code KAM

K922902 is an FDA 510(k) premarket notification submitted by Boston Medical Products, Inc. for the device "SALMAN SINUS BUTTON". The FDA issued a decision of Substantially Equivalent on May 18, 1993. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Boston Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1993
Date Received
June 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Sinus
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 KAM

  • K110687 — RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) (October 7, 2011)
  • K093594 — MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER (March 3, 2010)
  • K083574 — RELIEVA STRATUS MICROFLOW SPACER (January 29, 2009)
  • K072891 — SINUS SPACER (March 19, 2008)
  • K073041 — RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER (March 11, 2008)
  • K071845 — RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A (September 28, 2007)
  • K062458 — ETHMOID SINUS SPACER (September 15, 2006)
  • K060974 — RELIENT NAVIGATION DEVICE (May 5, 2006)
  • K050340 — MICROMEDICS SPHENOID SINUS STENT (April 27, 2005)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)

FDA data resources