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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 K863326
Device Name BONE MARROW 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 Number878.4800
Classification Product Code
GAA  
Date Received08/27/1986
Decision Date 09/16/1986
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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