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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 K020523
Device Name BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
Applicant
Bd
One Becton Dr. Mc226
Franklin Lakes,  NJ  07417
Applicant Contact PASQUALE AMOTO
Correspondent
Bd
One Becton Dr. Mc226
Franklin Lakes,  NJ  07417
Correspondent Contact PASQUALE AMOTO
Regulation Number880.5570
Classification Product Code
SCL  
Date Received02/19/2002
Decision Date 03/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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