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510(k) K933798

NU-PREP GEL by Cadwell Laboratories, Inc. — Product Code GXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1994
Date Received
August 4, 1993
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 by Cadwell Laboratories, Inc.

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  • K042350 — TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR (November 3, 2004)
  • K040932 — EASYNET BODY POSITION MODULE (July 1, 2004)
  • K040986 — CADWELL LIMB MOVEMENT MODULE (July 1, 2004)
  • K971214 — KILOWIN (June 11, 1998)
  • K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962455 — FOUR-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962457 — TWO-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K946094 — CADWELL EASY AMBULATORY EEG (September 12, 1995)

Other clearances for product code GXB

  • K143068 — Medical Monofilament Sensory Screening Toool (January 14, 2015)
  • 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)