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510(k) K900355

MARK VII THERMOREGULATION ASSIST SYSTEM by Life Enhancement Technologies, LLC — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1990
Date Received
January 25, 1990
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

Other clearances by Life Enhancement Technologies, LLC

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  • K873200 — KARLSON OZONE STERILIZER MODEL 100B (January 27, 1989)

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  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)