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510(k) K032242

PERSONNA PLUS SAFETY SCALPEL SYSTEM by Omi Manufacturing Pty., Ltd. — Product Code GES

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2003
Date Received
July 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Blade, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Omi Manufacturing Pty., Ltd.

  • K060971 — OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS (October 24, 2006)

Other clearances for product code GES

  • 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)
  • K873142 — PERSONNA DISPOSABLE SCALPEL (September 4, 1987)