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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Absorbent Tipped, Non-Sterile
510(k) Number K013820
Device Name FINN CHAMBER (R)
Applicant
Epitest Ltd. OY
1330a Redwood Way
Petaluma,  CA  94954
Applicant Contact CLAWSON BOWMAN
Correspondent
Epitest Ltd. OY
1330a Redwood Way
Petaluma,  CA  94954
Correspondent Contact CLAWSON BOWMAN
Regulation Number880.6025
Classification Product Code
KXF  
Date Received11/16/2001
Decision Date 01/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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