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510(k) K894611

CATHETER CARE KITS by L H M Ent., Inc. — Product Code FOZ

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
December 15, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by L H M Ent., Inc.

  • K901079 — SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER (May 18, 1990)
  • K901078 — SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE (May 18, 1990)
  • K894610 — CUSTOM TRAYS, KITS (March 15, 1990)
  • K900439 — SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC (February 15, 1990)
  • K883506 — IRRIGATION KIT (December 13, 1988)

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