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510(k) K965245

TBD by Utah Medical Products, Inc. — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1997
Date Received
December 31, 1996
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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