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510(k) K132048

BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET by Molnlycke Health Care Us, LLC — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2013
Date Received
July 2, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Molnlycke Health Care Us, LLC

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  • K191869 — Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, (March 13, 2020)
  • K190077 — Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Under (May 24, 2019)
  • K161939 — Avance Abdominal Dressing Kit (November 17, 2016)
  • K161935 — Avance Foam Dressing Kit - XL (November 4, 2016)
  • K161948 — Avance Gauze Dressing Kits (November 3, 2016)
  • K161797 — Avance Tubing, Avance Y-Connector, Avance ViewPad (October 19, 2016)

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  • K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)
  • K232638 — FilteredFlo Warming Blankets (October 24, 2023)
  • K232844 — The IQoolTM System (October 4, 2023)
  • K232508 — Barrier EasyWarm Active Self-Warming Blanket (September 15, 2023)
  • K231596 — IOB Temperature Management System (June 30, 2023)