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510(k) K944596

GRAHAM-FIELD ULTRASOUND LOTION by Chester Labs, Inc. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1995
Date Received
September 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by Chester Labs, Inc.

  • K041060 — E-Z LUBRICATING JELLY (May 7, 2004)
  • K001705 — STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MO (June 29, 2000)
  • K001593 — MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE (June 14, 2000)
  • K944599 — GRAHAM-FIELD CONDUCTIVE ECG SPRAY (May 7, 1996)
  • K944598 — GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL (May 7, 1996)
  • K944600 — GRAHAM-FIELD SALINE ELECTROLYTE GEL (November 20, 1995)
  • K944597 — GRAHAM-FIELD ULTRASOUND SCANNING GEL (June 21, 1995)
  • K940256 — BIOSHIELD BLUE LATEX GLOVES (March 23, 1994)
  • K940254 — BIOSHIELD BLUE POWDER FREE GLOVE (March 23, 1994)
  • K841871 — LIQUA-SONIC GEL (March 14, 1985)

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