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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K944837
Device Name MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE
Applicant
Medical Device Technologies, Inc.
4445 SW 35th Ter.
Suite 310
Gainsville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Medical Device Technologies, Inc.
4445 SW 35th Ter.
Suite 310
Gainsville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/30/1994
Decision Date 10/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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