FDA 510(k) Application Details - K031630

Device Classification Name

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510(K) Number K031630
Device Name BIFURCATED ALLERGY SKIN TESTING NEEDLE
Applicant PRECISION MEDICAL PRODUCTS, INC.
12 INDUSTRIAL WAY
DENVER, PA 17517 US
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Contact RONALD D WOLFE
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Regulation Number

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Classification Product Code SCL
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Date Received 05/27/2003
Decision Date 08/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K031630


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