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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Biopsy, Cardiovascular
510(k) Number K921418
Device Name ULTRA-CORE BIOPSY NEEDLES
Applicant
Medical Device Technologies, Inc.
4445 SW 35th Ter.
Suite 310
Gainsville,  FL  32608
Applicant Contact PAUL BAKER
Correspondent
Medical Device Technologies, Inc.
4445 SW 35th Ter.
Suite 310
Gainsville,  FL  32608
Correspondent Contact PAUL BAKER
Regulation Number878.4800
Classification Product Code
DWO  
Date Received03/24/1992
Decision Date 06/19/1992
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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