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510(k) K962596

CUSTOMED BLOOD EXTRACTION KIT by Customed, Inc. — Product Code GJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1996
Date Received
July 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Customed, Inc.

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  • K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) (December 4, 1997)
  • K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277 (November 25, 1996)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 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)
  • K925018 — IV PREP KIT W/O DRESSING (NON-STERILE) (August 27, 1993)

Other clearances for product code GJE

  • K925468 — JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (April 11, 1994)
  • K780303 — AUTO ISO-FILTER COLLECTION TUBE CAP (March 30, 1978)
  • K771489 — RTERIAL BLOOD SAMPLING KIT (August 22, 1977)
  • K771370 — ICROTAINEO BRAND TUBE (August 3, 1977)
  • K761177 — SODIUM CITRATE (January 10, 1977)
  • K760086 — TRAY, BLOOD SAMPLING (PULSATOR II) (July 16, 1976)