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510(k) K821737

DISP. MICROSURGICAL KNIVES by Coburn Optical Ind., Inc. — Product Code GES

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1982
Date Received
June 14, 1982
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

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  • K892347 — MAGNILINK SYSTEM 101 (May 26, 1989)
  • K862188 — IRRIGATION & ASPIRATION/VITRECTOMY DEVICE (August 21, 1986)
  • K853457 — COBURN I/A SYSTEM (October 15, 1985)
  • K812441 — DI-CROWN (October 6, 1981)
  • K803159 — AUTOMATED PERIMETERS (February 4, 1981)
  • K801659 — BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE (September 9, 1980)

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)