510(k) K951167

EMS I.V. START KIT by Emergency Medical Supply, Inc. — Product Code LRS

Clearance Details

Decision: SN ()
Decision Date: May 16, 1995
Date Received: March 14, 1995
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 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)
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)
K925018 — IV PREP KIT W/O DRESSING (NON-STERILE) (August 27, 1993)