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510(k) K925677

AUTOCHILL ACCESSORY KIT by Aircast, Inc. — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1993
Date Received
July 16, 1992
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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  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)