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510(k) K051227

RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 by Renu Medical, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2006
Date Received
May 12, 2005
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 Renu Medical, Inc.

  • K203847 — Reprocessed Tri Pulse Compression Garment (May 7, 2021)
  • K121145 — RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL (June 12, 2012)
  • K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (November 16, 2011)
  • K093658 — RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS (January 14, 2010)
  • K081927 — RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO (February 6, 2009)
  • K072194 — RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 (November 29, 2007)
  • K063661 — RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 (May 25, 2007)
  • K031559 — RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES (November 12, 2003)

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