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510(k) K014239

MEDSURG EQUIPMENT COVERS by International Medsurg Connection — Product Code MMP

K014239 is an FDA 510(k) premarket notification submitted by International Medsurg Connection for the device "MEDSURG EQUIPMENT COVERS". The FDA issued a decision of Substantially Equivalent on February 19, 2002. The device falls under product code MMP (Cover, Barrier, Protective), a Class II device regulated under 21 CFR 878.4370. International Medsurg Connection has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2002
Date Received
December 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Barrier, Protective
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by International Medsurg Connection

  • K110656 — IMC BLOOD COLLECTION NEEDLE (August 18, 2011)
  • K110882 — IMC INSULIN SYRINGE (August 18, 2011)
  • K102584 — IMC HYPODERMIC NEEDLE (January 14, 2011)
  • K102969 — IMC PISTON SYRINGES (December 20, 2010)
  • K100991 — IMC SURGICAL DRAPE (October 5, 2010)
  • K100846 — IMC SURGICAL FACE MASK (August 16, 2010)
  • K100208 — IMC SURGICAL DRAPE (April 20, 2010)
  • K052169 — IMC SURGICAL DRAPES (November 17, 2005)
  • K042893 — UNDER BUTTOCKS DRAPE (March 11, 2005)
  • K023808 — IRRIGATION SETS (March 10, 2003)

Other clearances for product code MMP

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K043234 — LIGHT DRAPE (May 25, 2005)
  • K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (November 30, 2004)
  • K040794 — INCUBATOR CAPE (June 10, 2004)
  • K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERS (September 22, 2003)
  • K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (February 4, 2003)
  • K970885 — ULTRASOUND SYSTEMS DRAPE (September 22, 1997)
  • K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (January 30, 1997)
  • K961699 — EQUIPMENT COVERS (August 23, 1996)
  • K952241 — PROTOUCH OVERGLOVE (August 7, 1995)

FDA data resources