FDA 510(k) Application Details - K050557

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K050557
Device Name Catheter, Conduction, Anesthetic
Applicant AMERICAN MEDICAL TECHNOLOGIES, INC.
1211 WEST 13TH ST.
RIVIERA BEACH, FL 33404 US
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Contact MICHAEL RENICK
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Regulation Number 868.5120

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Classification Product Code BSO
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Date Received 03/03/2005
Decision Date 05/27/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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