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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 K012515
Device Name BIFURCATED VACCINATING 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 Received08/06/2001
Decision Date 09/19/2001
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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