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510(k) K053250

ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT by Advanced Neuromodulation Systems — Product Code GZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2005
Date Received
November 21, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5880
Review Panel
NE
Submission Type

Other clearances by Advanced Neuromodulation Systems

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  • K081208 — CINCH ANCHOR, MODEL 1194 (July 18, 2008)
  • K072462 — WIDE SPACED QUATTRODE LEADS (October 11, 2007)
  • K070847 — TRIAL CABLE, 3009 (April 11, 2007)
  • K063080 — TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS (December 12, 2006)
  • K052374 — RAPID PROGEAMMER 3.0 (November 22, 2005)
  • K052418 — AXXESS BUTTERFLY ANCHOR (September 26, 2005)
  • K050922 — ANS SCS ACCESSORY KIT (May 18, 2005)
  • K050633 — TRIAL CABLE RETENTION CLIP (April 21, 2005)

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