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510(k) K011515

MEDLINE GROUNDING PAD by Medline Industries, Inc. — Product Code JOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2001
Date Received
May 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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  • K003403 — ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 (May 7, 2001)
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  • K991830 — CAPSULAR SHRINKAGE ELECTRODE (August 20, 1999)
  • K974735 — STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLA (June 24, 1998)
  • K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (December 19, 1997)
  • K971187 — STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE (May 5, 1997)