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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K021387
Device Name POLAR WAND
Applicant
CHEK-MED SYSTEMS
25 VILLAGE HILL RD.
WILLINGTON,  CT  06279
Applicant Contact ROB WHALEN
Correspondent
CHEK-MED SYSTEMS
25 VILLAGE HILL RD.
WILLINGTON,  CT  06279
Correspondent Contact ROB WHALEN
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/02/2002
Decision Date 07/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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