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510(k) K042145

READY-HEAT BLANKET by Techtrade, LLC — Product Code KME

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2004
Date Received
August 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bedding, Disposable, Medical
Device Class
Class I
Regulation Number
880.6060
Review Panel
HO
Submission Type

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  • K050097 — TECHNO-SCOPE VISUAL STETHOSCOPE (September 30, 2005)

Other clearances for product code KME

  • K944953 — OREX MEDICAL BEDDING (December 2, 1994)
  • K933636 — DISPOSE-A-SHEET (January 26, 1994)
  • K932539 — DOCTOR DOWN --RESCUE WRAP (November 2, 1993)
  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)
  • K912257 — CHEM-SLEEVE B (December 31, 1991)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911948 — MEDI GUARD PILLOWCASE (May 28, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)
  • K911950 — MEDI GUARD DRAPES (May 21, 1991)