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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, catheter
510(k) Number K955433
Device Name DURALASTIC SILICONE TUBING
Applicant
ALLIED BIOMEDICAL CORP.
3850 DR.
#C-2
PASO ROBLES,  CA  93446
Applicant Contact GERALD HANSON
Correspondent
ALLIED BIOMEDICAL CORP.
3850 DR.
#C-2
PASO ROBLES,  CA  93446
Correspondent Contact GERALD HANSON
Regulation Number878.4200
Classification Product Code
KGZ  
Date Received11/28/1995
Decision Date 01/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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