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510(k) K102584

IMC HYPODERMIC NEEDLE by International Medsurg Connection — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2011
Date Received
September 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
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)
  • 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)
  • K022159 — PISTON SYRINGE & HYPODERMIC NEEDLE (November 7, 2002)

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