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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K891164
Device Name SAMUELS - MICRO -SCLER CATHETER
Applicant
POLYVAL, INC.
5108 WALNUT GROVE AVE.
SAN GABRIEL,  CA  91775
Applicant Contact NED BUCKMAN
Correspondent
POLYVAL, INC.
5108 WALNUT GROVE AVE.
SAN GABRIEL,  CA  91775
Correspondent Contact NED BUCKMAN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/06/1989
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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