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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, Reusable
510(k) Number K971114
Device Name BIOACCESS MARROW HARVEST SYSTEM
Applicant
Bioaccess, Inc.
8400 Cedar St.
Silver Spring,  MD  20910
Applicant Contact PETER J CARNES
Correspondent
Bioaccess, Inc.
8400 Cedar St.
Silver Spring,  MD  20910
Correspondent Contact PETER J CARNES
Regulation Number878.4800
Classification Product Code
GDM  
Date Received03/26/1997
Decision Date 06/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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