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510(k) K012956

HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB by Hygia Health Services, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2002
Date Received
September 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Hygia Health Services, Inc.

  • K100523 — ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENS (May 4, 2010)
  • K090074 — HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS (April 22, 2009)
  • K080424 — HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1 (May 28, 2008)
  • K053575 — HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS (February 15, 2006)
  • K041867 — HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, (September 10, 2004)
  • K032821 — HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF (December 5, 2003)
  • K012715 — HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II (August 1, 2003)
  • K021509 — HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 (December 24, 2002)
  • K012654 — HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DV (April 12, 2002)
  • K012650 — HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP (April 12, 2002)

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