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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K840391
Device Name ANGIOGRAPHIC PROCEDURE TRAY
Applicant
Triad Medical Division
6087 Buford Hwy. B 104
Norcross,  GA  30071
Applicant Contact BUD BOYNTON
Correspondent
Triad Medical Division
6087 Buford Hwy. B 104
Norcross,  GA  30071
Correspondent Contact BUD BOYNTON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/30/1984
Decision Date 08/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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