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510(k) K904240

SINGLE USE LAPARSCOPIC ELECTRODE by Aspen Labs — Product Code HFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1991
Date Received
September 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Laparoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

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  • K905654 — ELECTROSURGICAL UNIT WITH ACCESSORIES (March 18, 1991)

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