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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Biopsy, Cardiovascular
510(k) Number K872597
Device Name FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE
Applicant
Dianon Systems, Inc.
200 Watson Blvd.
Stratford,  CT  06497
Applicant Contact FOEMMEL, PHD
Correspondent
Dianon Systems, Inc.
200 Watson Blvd.
Stratford,  CT  06497
Correspondent Contact FOEMMEL, PHD
Regulation Number878.4800
Classification Product Code
DWO  
Date Received07/02/1987
Decision Date 07/28/1987
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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