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510(k) K002859

SSW-STERILE SOLUTION WARMER by Kmi Kolster Methods, Inc. — Product Code LHC

K002859 is an FDA 510(k) premarket notification submitted by Kmi Kolster Methods, Inc. for the device "SSW-STERILE SOLUTION WARMER". The FDA issued a decision of Substantially Equivalent on November 16, 2000. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. Kmi Kolster Methods, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2000
Date Received
September 13, 2000
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 Kmi Kolster Methods, Inc.

  • K060414 — KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE (October 23, 2006)
  • K043591 — FEATHERLIFT EXTENDED APTOS THREAD (March 4, 2005)
  • K012236 — STARS2000 POWER CANNULA (November 19, 2001)
  • K010702 — XUB EXTERNAL ULTRASOUND (August 9, 2001)
  • K991203 — IRRIGATION OR INFUSION PUMP K PUMP (October 15, 1999)

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)
  • K051819 — C CHANGE SOLUTION WARMER (August 15, 2005)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K023282 — ORS-3000LD (November 13, 2002)

FDA data resources