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510(k) K924809

IRRIGATION TRAY W/ BULB SYRINGE by Customed, Inc. — Product Code KYZ

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 7, 1993
Date Received
September 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Non Dental)
Device Class
Class I
Regulation Number
880.6960
Review Panel
HO
Submission Type

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  • K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277 (November 25, 1996)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K962596 — CUSTOMED BLOOD EXTRACTION KIT (September 27, 1996)
  • K961442 — UNIVERSAL DRAINAGE TRAY (May 9, 1996)
  • K953678 — STERIMED STERIZATION WRAPPER (NON-STERILE) (October 2, 1995)
  • K950295 — WOUND CLOSURE/LACERATION TRAY (April 18, 1995)
  • K942177 — FOLEY CATHETERIZATION TRAY (September 8, 1994)
  • K925017 — IV PREP KIT (NON-STERILE) (August 27, 1993)

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