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510(k) K940160

TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM by Burke Neutech, Inc. — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
January 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type

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  • K945803 — THERMAFLEX, MODEL SD 55 C.P.M.H. (May 11, 1995)
  • K942926 — NEURO-AIDE (August 3, 1994)
  • K926151 — LSI6000 THERMAL THERAPY SYSTEM (May 26, 1993)

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