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510(k) K032239

THERA-CREAM, MODEL TCT004 by Prizm Medical, Inc. — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2004
Date Received
July 21, 2003
Clearance Type
Traditional
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 Prizm Medical, Inc.

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  • K012974 — PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 (July 23, 2002)
  • K951727 — Z-WATCH SYSTEM (November 21, 1995)
  • K944487 — ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES (February 21, 1995)
  • K932299 — ELECTRO-MESH (July 1, 1994)

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