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510(k) K954716

DEROYAL INDUSTRIES INFANT HEEL WARMER by Debusk Knitting Mills, Div. Deroyal Industries — Product Code MPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1996
Date Received
October 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infant Heel Warmer (Chemical Heat Pack)
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

Other clearances by Debusk Knitting Mills, Div. Deroyal Industries

  • K961097 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES (June 3, 1996)
  • K961085 — DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING (May 21, 1996)
  • K961087 — DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS (May 16, 1996)

Other clearances for product code MPO

  • K221154 — Infant Heel WarmerTM; Heel Snuggler® (October 7, 2022)
  • K151845 — Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (March 18, 2016)
  • K150627 — Rapid Aid Instant Disposable Infant Heel Warmer (May 27, 2015)
  • K103549 — DENOVO TEDDY GEL INFANT HEEL WARMER (April 8, 2011)
  • K053254 — INFANT HEEL WARMER BY INTCO (September 19, 2006)
  • K040856 — RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (May 3, 2004)
  • K040044 — HEEL SNUGGLER, MODEL 99047 (January 27, 2004)
  • K032989 — MEDI-HEAT INFANT HEEL WARMER (October 22, 2003)
  • K964523 — RECOVER INFANT HEEL WARMER (5100) (February 10, 1997)
  • K961154 — BAXTER SODIUM ACETATE INFANT HEEL WARMER (June 6, 1996)