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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, delivery, allergen and vaccine
510(k) Number K031630
Device Name BIFURCATED ALLERGY SKIN TESTING NEEDLE
Applicant
PRECISION MEDICAL PRODUCTS, INC.
12 INDUSTRIAL WAY
DENVER,  PA  17517
Applicant Contact RONALD D WOLFE
Correspondent
PRECISION MEDICAL PRODUCTS, INC.
12 INDUSTRIAL WAY
DENVER,  PA  17517
Correspondent Contact RONALD D WOLFE
Classification Product Code
LDH  
Date Received05/27/2003
Decision Date 08/07/2003
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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