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510(k) K001328

Device
INTRODUCER SHEATH
Applicant
NOVASYS MEDICAL, INC.
510(k) number
K001328
Product code
FEC  
Decision
Substantially Equivalent (SESE)
Decision date
2000-07-17
Date received
2000-04-26
Regulation
876.1500
Classification name
Obturator, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS C WEHMAN
Address
687 # Pastoria Ave. Sunnyvale CA US 94086 94086

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FEC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K760172OBTURATOR, VISUALV. Mueller O.V. Baxter Healthcare Corp.1976-12-02
K760183OBTURATOR, DEFLECTINGV. Mueller O.V. Baxter Healthcare Corp.1976-12-02

Legacy Summary#

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FDA Review#

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