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510(k) K853552

SENTRY FLEXIBLE TENS by Sentry Medical Products, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1985
Date Received
August 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Sentry Medical Products, Inc.

  • K962122 — SENTRY RADIOTRANSLUCENT ECG ELECTRODES (July 24, 1996)
  • K955636 — SENTRY DISPOSABLE DISPERSIVE ELECTRODE (March 27, 1996)
  • K942827 — SENTRY INSERTION TRAY (November 2, 1994)
  • K934000 — SENTRY AQUEOUS GEL ECG ELECTRODES (August 30, 1994)
  • K935098 — BABY BOARD (February 15, 1994)
  • K933603 — LEADWIRE (January 18, 1994)
  • K932704 — PATIENT CABLE (December 27, 1993)
  • K881670 — ACCUTEMP PLUS (November 22, 1988)
  • K881343 — DURADERM BUTTERFLY (May 4, 1988)
  • K851522 — DIAGNOSTIC ECG DISPOSABLE ELECTRODE (October 24, 1985)

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