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510(k) K843101

KARL STORZ 27086KC ULTRASONIC LITHOTRI by KARL STORZ Endoscopy-America, Inc. — Product Code FEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1984
Date Received
August 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Ultrasonic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

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