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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K854579
Device Name HYPODERMIC NEEDLE AND STYLET
Applicant
Berkley and Co.
Trilene Dr.
Spirit Lake,  IA  51360
Applicant Contact STEVE CARWELL
Correspondent
Berkley and Co.
Trilene Dr.
Spirit Lake,  IA  51360
Correspondent Contact STEVE CARWELL
Regulation Number878.4800
Classification Product Code
GAA  
Date Received11/15/1985
Decision Date 12/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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