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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 K980196
Device Name MD TECH BIOPSY SET FOR BONE AND BONE MARROW
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
4445 SW 35TH TERRACE
SUITE 310
GAINESVILLE,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
MEDICAL DEVICE TECHNOLOGIES, INC.
4445 SW 35TH TERRACE
SUITE 310
GAINESVILLE,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/20/1998
Decision Date 02/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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