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510(k) K022490

KSEA MEDI PACK by KARL STORZ Endoscopy-America, Inc. — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2003
Date Received
July 29, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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