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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 K895551
Device Name ROCKET BONE MARROW NEEDLE
Applicant
A & A Medical, Inc.
31a Business Park Dr.
Branford,  CT  06405
Applicant Contact CEDRIC K BERNBERG
Correspondent
A & A Medical, Inc.
31a Business Park Dr.
Branford,  CT  06405
Correspondent Contact CEDRIC K BERNBERG
Regulation Number878.4800
Classification Product Code
GDM  
Date Received09/13/1989
Decision Date 10/06/1989
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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