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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Allergen And Vaccine Delivery Needles
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
Regulation Number880.5570
Classification Product Code
SCL  
Date Received05/27/2003
Decision Date 08/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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