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510(k) K143068

Medical Monofilament Sensory Screening Toool by Medical Monofilament Manufacturing — Product Code GXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2015
Date Received
October 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esthesiometer
Device Class
Class I
Regulation Number
882.1500
Review Panel
NE
Submission Type

Other clearances for product code GXB

  • K933798 — NU-PREP GEL (April 22, 1994)
  • K871571 — NEUROTIPS(TM) (June 18, 1987)
  • K801907 — ALGESIOMETER (September 16, 1980)
  • K772406 — AESTHESIOMETER (January 6, 1978)
  • K771847 — TEMP-TESTER (November 2, 1977)
  • K761133 — AESTHESIOMETER (December 2, 1976)