FDA 510(k) Application Details - K974742

Device Classification Name Trocar

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510(K) Number K974742
Device Name Trocar
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 870.1390

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Classification Product Code DRC
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Date Received 12/19/1997
Decision Date 04/06/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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