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510(k) K760910

DISPOSABLE K-PADS by Gorman Rupp Industries — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1976
Date Received
October 27, 1976
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 Gorman Rupp Industries

  • K771537 — AQUAMATIC K-MODULE MODEL K-20 (September 6, 1977)
  • K770839 — AQUAMATIC K-77 (June 8, 1977)
  • K770232 — BLOOD/FLUID WARMER MODEL DW-1000A (February 14, 1977)
  • K761337 — AQUAMATIC K-MODULE MODEL K-10 (January 10, 1977)
  • K761087 — ELECTRONIC CONTROL UNIT (December 6, 1976)

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  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)