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510(k) K925022

SURGICAL TRAY (STERILE) by Customed, Inc. — Product Code LRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1993
Date Received
September 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Ent Drug
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
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)

Other clearances for product code LRD

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  • K942789 — MISTASSIST (August 12, 1994)
  • K940133 — THE EXPANDACELL EAR PACK (May 23, 1994)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)