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510(k) K022097

THERMIQUE by Parkell, Inc. — Product Code EAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2002
Date Received
June 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pulp
Device Class
Class II
Regulation Number
872.1720
Review Panel
DE
Submission Type

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Other clearances for product code EAT

  • K021298 — ELEMENTS DIAGNOSTIC UNIT (June 19, 2002)
  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • K011666 — CHILLIT (August 6, 2001)
  • K990225 — ENDO ANALYZER, MODEL 8005, MODIFIED (February 25, 1999)
  • K973439 — ENDO ANALYZER, MODEL 8005 (December 8, 1997)
  • K970715 — SYSTEM B HEAT SOURCE (April 7, 1997)
  • K963862 — TOUCH N' HEAT (December 2, 1996)
  • K960799 — ORTHO-ICE (May 9, 1996)
  • K950237 — DIGITEST (June 9, 1995)
  • K950238 — GENTAL PULSE (May 9, 1995)