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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, vascular
510(k) Number K881448
Device Name #557 DISPOSABLE CARDIOVASCULAR CLAMP
Applicant
ALPHA INDUSTRIES, INC.
P.O. BOX 808
701 NORTH GREENWOOD AVE.
CLEARWATER,  FL  33517
Applicant Contact BRENT E MAGERS
Correspondent
ALPHA INDUSTRIES, INC.
P.O. BOX 808
701 NORTH GREENWOOD AVE.
CLEARWATER,  FL  33517
Correspondent Contact BRENT E MAGERS
Regulation Number870.4450
Classification Product Code
DXC  
Date Received04/06/1988
Decision Date 06/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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