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510(k) K033730

PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES by Pmt Corp. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2004
Date Received
November 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

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  • K042901 — ENDOMARK STERILE INDIA INK (March 16, 2005)
  • K972597 — PMT NEW BEGINNINGS GELSHAPES & AMEND (October 1, 1997)
  • K970418 — PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) (April 29, 1997)
  • K964224 — STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTR (March 19, 1997)
  • K935560 — PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) (November 7, 1994)
  • K933079 — ELECTROCAUTERY SYSTEM MODEL 1980 (February 22, 1994)
  • K935499 — PMT SILICONE SHEETING (February 10, 1994)

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