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510(k) K001705

STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF by Chester Labs, Inc. — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2000
Date Received
June 5, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Chester Labs, Inc.

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  • K944598 — GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL (May 7, 1996)
  • K944599 — GRAHAM-FIELD CONDUCTIVE ECG SPRAY (May 7, 1996)
  • K944600 — GRAHAM-FIELD SALINE ELECTROLYTE GEL (November 20, 1995)
  • K944597 — GRAHAM-FIELD ULTRASOUND SCANNING GEL (June 21, 1995)
  • K944596 — GRAHAM-FIELD ULTRASOUND LOTION (June 7, 1995)
  • K940254 — BIOSHIELD BLUE POWDER FREE GLOVE (March 23, 1994)
  • K940256 — BIOSHIELD BLUE LATEX GLOVES (March 23, 1994)
  • K841871 — LIQUA-SONIC GEL (March 14, 1985)

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