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510(k) K964113

IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL by M-Pact Worldwide Management Corp. — Product Code EMX

K964113 is an FDA 510(k) premarket notification submitted by M-Pact Worldwide Management Corp. for the device "IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL". The FDA issued a decision of Substantially Equivalent on November 7, 1996. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. M-Pact Worldwide Management Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1996
Date Received
October 15, 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 M-Pact Worldwide Management Corp.

  • K971832 — IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVAL (July 31, 1997)
  • K971473 — IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (July 7, 1997)

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