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510(k) K003608

SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY by Aesculap, Inc. — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2001
Date Received
November 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type

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