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510(k) K950125

Device
KARL STORZ BOUGIES AND DILATORS
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
510(k) number
K950125
Product code
FAX  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-07
Date received
1995-01-12
Regulation
876.5520
Classification name
Bougie, Urological
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BETTY M JOHNSON
Address
600 Corporate Pt.e Culver City CA US 90230 90230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FAX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822711ANTI-MIST, ANTI-FOG EYEGLASS & DENTALParker Laboratories, Inc.1982-11-03

Legacy Summary#

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FDA Review#

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