510(k) K962595

KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS by KARL STORZ Endoscopy-America, Inc. — Product Code FFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1996
Date Received
July 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type