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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 K072453
Device Name CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T
Applicant
Brymill Corp.
105 Windermere Ave., Bldg. 2
Windermere Industrial Park
Ellington,  CT  06029
Applicant Contact STEPHEN WILLIAMS
Correspondent
Brymill Corp.
105 Windermere Ave., Bldg. 2
Windermere Industrial Park
Ellington,  CT  06029
Correspondent Contact STEPHEN WILLIAMS
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
FQZ  
Date Received08/31/2007
Decision Date 12/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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