FDA 510(k) Application Details - K974741

Device Classification Name Needle, Aspiration And Injection, Disposable

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510(K) Number K974741
Device Name Needle, Aspiration And Injection, Disposable
Applicant MEDICAL DEVICE TECHNOLOGIES, INC.
4445 SW 35TH TERRACE
SUITE 310
GAINESVILLE, FL 32608 US
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Contact KARL SWARTZ
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Regulation Number 878.4800

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Classification Product Code GAA
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Date Received 12/19/1997
Decision Date 01/08/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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