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510(k) K040044

HEEL SNUGGLER, MODEL 99047 by Respironics, Inc. — Product Code MPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2004
Date Received
January 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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Other clearances for product code MPO

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  • K150627 — Rapid Aid Instant Disposable Infant Heel Warmer (May 27, 2015)
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  • K053254 — INFANT HEEL WARMER BY INTCO (September 19, 2006)
  • K040856 — RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (May 3, 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)
  • K954716 — DEROYAL INDUSTRIES INFANT HEEL WARMER (January 11, 1996)