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510(k) K021387

POLAR WAND by Chek-Med Systems — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2002
Date Received
May 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Chek-Med Systems

  • K041783 — POLAR WAND (September 28, 2004)
  • K993951 — SPOT ENDOSCOPIC MARKER (February 18, 2000)

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