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510(k) K900857

NON STERILE PARENTERAL SUPPLY KIT by Intermed, Inc. — Product Code FMF

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
May 22, 1990
Date Received
February 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Intermed, Inc.

  • K842166 — INTERMED, INS STERILE WATER/SALINE (February 12, 1985)
  • K833126 — DRESSING CHANGE TRAYS (January 27, 1984)
  • K833574 — PERCUTANEOUS SHEATH INTRODUCER TRAYS (January 11, 1984)
  • K833573 — CENTRAL VEIN CATH. TRAY CC-20-1420 (January 11, 1984)
  • K833139 — ACUTE HEMODIALYSIS TRAYS (December 22, 1983)
  • K833059 — SUCTION CATHETER TRAYS (December 12, 1983)
  • K821269 — TRACHEOSTOMY CARE TRAYS (May 27, 1982)
  • K791427 — CATHETERIZATION TRAYS FOLEY AND URETHRAL (September 7, 1979)
  • K791426 — PERITONEAL PAC (August 28, 1979)
  • K781748 — IRRIGATION TRAY (December 12, 1978)

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