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510(k) K854860

BLADES, SCALPEL CARBON STEET by Medelec Intl. Corp. — Product Code GES

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1985
Date Received
December 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)
  • K863491 — BLOOD SPECIMEN COLLECTION DEVICES (October 24, 1986)
  • 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)

Other clearances for product code GES

  • K032242 — PERSONNA PLUS SAFETY SCALPEL SYSTEM (September 23, 2003)
  • K932998 — EASY-ON (August 18, 1993)
  • K923170 — LOS ALAMOS RETRACTABLE KNIFE (February 18, 1993)
  • K915119 — SCALPEL BLADE REMOVER (BLADEGARD) (May 5, 1992)
  • K911913 — PRECISION GLIDE - ENHANCED SURGICAL BLADE (May 13, 1991)
  • K900266 — STERILE CARBON STEEL SURGICAL BLADE (March 1, 1990)
  • K884862 — ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (December 27, 1988)
  • K881638 — SURGICAL BLADE (June 15, 1988)
  • K880244 — SURGICAL BLADES (February 10, 1988)
  • K873493 — NINJA SCALPEL (September 24, 1987)