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510(k) K953593

Device
RUSCH TRACHEAL BRONCHIAL Y STENT
Applicant
RUSCH, INC.
510(k) number
K953593
Product code
NYT  
Decision
Se Subject To Tracking Reg (ST)
Decision date
1995-10-13
Date received
1995-07-31
Regulation
878.3720
Classification name
Prosthesis, Tracheal, Expandable, Polymeric
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KARENANN J BROZOWSKI
Address
Tall Pines Park Jeffrey NH US 03452 03452

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NYT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013266RUSCH POLYFLEX STENT KITRusch Intl.2001-11-27
K982614RUSCH POLYFLEX STENT KITRusch Intl.1998-12-04

Legacy Summary#

summary

FDA Review#

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