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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 K961959
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 Number878.4800
Classification Product Code
GAA  
Subsequent Product Code
GDM  
Date Received05/20/1996
Decision Date 07/19/1996
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
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