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510(k) K922533

IV START KIT CUSTOM SMP # A-Z by Specialty Medical Products Co. — Product Code LRS

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 23, 1993
Date Received
May 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
I.V. Start Kit
Device Class
Class II
Regulation Number
880.5200
Review Panel
SU
Submission Type

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Specialty Medical Products Co.

  • K924707 — VARIOUS ANESTHETIC KITS OR TRAYS (June 17, 1993)
  • K922845 — BASIC DRESSING CHANGE TRAY SMP 102A (December 29, 1992)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)

Other clearances for product code LRS

  • K050654 — AMSINO I.V. START KIT (May 2, 2005)
  • K001879 — INFUSION IV SET (November 20, 2001)
  • K963722 — IV START KIT (November 27, 1996)
  • K951167 — EMS I.V. START KIT (May 16, 1995)
  • K950184 — B. BRAUN IV START KITS (March 15, 1995)
  • K944041 — PERSONAL HEARING SYSTEM (December 27, 1994)
  • K943941 — SAFESTART VASCULAR ACCESS START KIT (October 20, 1994)
  • K935684 — IV START KIT (June 10, 1994)
  • K942238 — I.V. STARTPAK VASCULAR ACCESS START KIT (June 3, 1994)
  • K941469 — IV START KIT (May 12, 1994)