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510(k) K963856

RAND NASAL PACKING by Rand Scientific Corp. — Product Code EMX

K963856 is an FDA 510(k) premarket notification submitted by Rand Scientific Corp. for the device "RAND NASAL PACKING". The FDA issued a decision of Substantially Equivalent on October 18, 1996. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Rand Scientific Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1996
Date Received
September 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Epistaxis
Device Class
Class I
Regulation Number
874.4100
Review Panel
EN
Submission Type

Other clearances by Rand Scientific Corp.

  • K961081 — SPIRIT RIDGE SILICONE CARVING BLOCK (May 22, 1996)
  • K961057 — DURALASTIC SHEETING II (May 16, 1996)
  • K955777 — PMMA CLASIC (May 16, 1996)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K961124 — THE NAUTILUS (April 19, 1996)
  • K961071 — THE MAGNUM CHIN IMPLANT (April 19, 1996)
  • K961080 — MEDIAL MALAR IMPLANT (April 19, 1996)
  • K955366 — TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS (March 28, 1996)
  • K952165 — TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS (June 30, 1995)

Other clearances for product code EMX

  • K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint (November 14, 2022)
  • K041446 — NASALCEASE (July 1, 2004)
  • K000108 — RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR- (May 23, 2000)
  • K993362 — HYLASINE (March 13, 2000)
  • K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING (September 14, 1999)
  • K982731 — MEROGEL NASAL DRESSING AND SINUS STENT (February 2, 1999)
  • K984069 — ENTAXIS NASAL PACKING (January 25, 1999)
  • K981966 — NOSEBLEED NOSECLIP (August 14, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)

FDA data resources