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510(k) K053254

INFANT HEEL WARMER BY INTCO by Shanghai Intco Medical Supply Co., Ltd. — Product Code MPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2006
Date Received
November 21, 2005
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

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