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510(k) K051819

C CHANGE SOLUTION WARMER by C Change Surgical, LLC — Product Code LHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2005
Date Received
July 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type

Other clearances by C Change Surgical, LLC

  • K083417 — INTRATEMP SOLUTION WARMER (January 13, 2009)

Other clearances for product code LHC

  • K153713 — Getinge Series Warming Cabinet (June 7, 2016)
  • K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (January 15, 2016)
  • K150190 — IntraTemp Solution Warmer (February 26, 2015)
  • K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (December 30, 2014)
  • K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE (August 28, 2014)
  • K083417 — INTRATEMP SOLUTION WARMER (January 13, 2009)
  • K080609 — SWC/DWC WARMING CABINETS (June 13, 2008)
  • K023282 — ORS-3000LD (November 13, 2002)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K021288 — ORS-1000LD (June 27, 2002)