FDA 510(k) Application Details - K964648

Device Classification Name Blood Pressure Cuff

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510(K) Number K964648
Device Name Blood Pressure Cuff
Applicant PROTECT ALL, INC.
228 GOLF COURSE RD.
PIEDMONT, SC 29673 US
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Contact J.K. MOSELEY
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 11/20/1996
Decision Date 02/18/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K964648


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