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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 K882105
Device Name CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM
Applicant
Dianon Systems, Inc.
200 Watson Blvd.
Stratford,  CT  06497
Applicant Contact PHILLENORE HOWARD
Correspondent
Dianon Systems, Inc.
200 Watson Blvd.
Stratford,  CT  06497
Correspondent Contact PHILLENORE HOWARD
Regulation Number878.4800
Classification Product Code
GAA  
Date Received05/19/1988
Decision Date 07/11/1988
Decision Substantially Equivalent - With Drug (SESD)
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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