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510(k) K944290

Device
CATHETERS, BILIARY CATHETERS, UROLOGICAL
Applicant
BOSTON SCIENTIFIC CORP.
510(k) number
K944290
Product code
FFA  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-08
Date received
1994-09-02
Regulation
876.5090
Classification name
Tube, Drainage, Suprapubic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LORRAIN M HANLEY
Address
780 Brookside Dr. Spencer IN US 47460 47460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FFA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K864770SUCTION TUBENew England Surgical Instrument Corp.1987-02-24
K833061C-FLEX PENROSE DRAINAGE TUBEConcept, Inc.1983-11-07

Legacy Summary#

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FDA Review#

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