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510(k) K881331

ORTHODONTIC NITINOL SPRINGS by Flexmedics — Product Code EJW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1988
Date Received
March 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clasp, Wire
Device Class
Class I
Regulation Number
872.3285
Review Panel
DE
Submission Type

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  • K952430 — FINESSE GUIDEWIRE CORONARY (August 18, 1995)
  • K943390 — FLEXFINDER GUIDEWIRE (June 27, 1995)
  • K942074 — FLEXFINDER GUIDEWIRE (June 24, 1994)
  • K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (January 21, 1994)
  • K912843 — FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (September 24, 1991)
  • K910674 — FLEXMEDICS MALLEABLE CANNULA (April 12, 1991)
  • K895899 — FLEXMEDICS GUIDEWIRE .012 ONLY (May 23, 1990)
  • K893626 — FLEXMEDICS GUIDEWIRE (September 26, 1989)

Other clearances for product code EJW

  • K901257 — WIRONTOM CLASP WIRE (April 25, 1990)
  • K872746 — VITALLIUM WIRE (July 21, 1987)