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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 K041783
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 Received07/01/2004
Decision Date 09/28/2004
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
Predetermined Change
Control Plan Authorized		 No
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