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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K850438
Device Name RENAL BIOPSY TRAY
Applicant
Packaging Technologies, Inc.
262 Gemini Ave.
Brea,  CA  92621
Applicant Contact ROBERT W FAIR
Correspondent
Packaging Technologies, Inc.
262 Gemini Ave.
Brea,  CA  92621
Correspondent Contact ROBERT W FAIR
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/05/1985
Decision Date 02/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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