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510(k) Premarket Notification Database

Device Classification Name catheter, retention type, balloon
510(k) NumberK944376
Device NameORION ALL SILICONE ELASTOMER COATED CATHETER
Applicant
REGULATORY & MARKETING SERVICES, INC.
1247 florida ave.
palm harbor,  FL  34682
Contactpatrick j lamb
Regulation Number876.5130
Classification Product Code
EZL
Date Received09/07/1994
Decision Date 11/30/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Statement/Summary/Purged Status Statement/purged 510(k)
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 02/06/2009

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