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510(k) K925333

SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE by Aspen Labs — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1994
Date Received
October 21, 1992
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

Other clearances by Aspen Labs

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  • K931215 — HAND-TROL S (March 28, 1994)
  • K912046 — SINGLE USE LEE ELECTRODE (March 5, 1992)
  • K905654 — ELECTROSURGICAL UNIT WITH ACCESSORIES (March 18, 1991)
  • K904240 — SINGLE USE LAPARSCOPIC ELECTRODE (February 19, 1991)

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