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510(k) K863491

BLOOD SPECIMEN COLLECTION DEVICES by Medelec Intl. Corp. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
September 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Medelec Intl. Corp.

  • K961013 — DISPOSABLE NEEDLE ELECTRODE (December 20, 1996)
  • K935017 — TD50 ELECTROMYOGRAPH (July 28, 1994)
  • K922548 — MEDELEC 2110 AND 2114 EEG (November 3, 1992)
  • K920127 — ELECTROENCEPHALOGRAPH RECORDING SYSTEM (June 10, 1992)
  • K912775 — SAPPHIRE 4ME EMG/EP SYSTEM (November 8, 1991)
  • K865106 — PROPHYLACTIC (CONDOM) MR. JOHNNY (May 20, 1987)
  • K854622 — PROPHYLACTIC (CONDOM) (April 11, 1986)
  • K854562 — CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I (January 9, 1986)
  • K854857 — SCALPEL, ONE-PIECE, DISPOSABLE (December 24, 1985)
  • K854860 — BLADES, SCALPEL CARBON STEET (December 24, 1985)

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