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510(k) K021288

ORS-1000LD by O.R. Solutions, Inc. — Product Code LHC

K021288 is an FDA 510(k) premarket notification submitted by O.R. Solutions, Inc. for the device "ORS-1000LD". The FDA issued a decision of Substantially Equivalent on June 27, 2002. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. O.R. Solutions, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2002
Date Received
April 23, 2002
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 O.R. Solutions, Inc.

  • K051979 — ORS MODEL 6000 ENDOSCOPE HOLDER (August 30, 2005)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K023282 — ORS-3000LD (November 13, 2002)
  • K021289 — WARMER 2000LD (June 26, 2002)
  • K960836 — DMS-9000 (September 12, 1996)
  • K953654 — ORS-111 (September 22, 1995)

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