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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K050557
Device Name AMT NANOCATH
Applicant
American Medical Technologies, Inc.
1211 W. 13th St.
Riviera Beach,  FL  33404
Applicant Contact MICHAEL RENICK
Correspondent
American Medical Technologies, Inc.
1211 W. 13th St.
Riviera Beach,  FL  33404
Correspondent Contact MICHAEL RENICK
Regulation Number868.5120
Classification Product Code
BSO  
Date Received03/03/2005
Decision Date 05/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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