510(k) K020640

KSEA SCB MEDIA CONTROL by KARL STORZ Endoscopy-America, Inc. — Product Code FTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2002
Date Received
February 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Accessories
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type