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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 K974741
Device Name MANAN ACCURA NEEDLE
Applicant
Medical Device Technologies, Inc.
4445 SW 35th Terrace
Suite 310
Gainsville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Medical Device Technologies, Inc.
4445 SW 35th Terrace
Suite 310
Gainsville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number878.4800
Classification Product Code
GAA  
Date Received12/19/1997
Decision Date 01/08/1998
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
Recalls CDRH Recalls
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