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FDA 510(k) Application Details - K010526
Device Classification Name
Aid, Cardiopulmonary Resuscitation
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510(K) Number
K010526
Device Name
Aid, Cardiopulmonary Resuscitation
Applicant
ELCARE INNOVATIONS, INC.
7101 STEPHENSON-LEVEY RD.
BURLESON, TX 76028 US
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Contact
ELROY T CANTRELL
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Regulation Number
870.5200
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Classification Product Code
LIX
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More FDA Info for this Product Code
Date Received
02/22/2001
Decision Date
12/13/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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