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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
510(k) Number K991923
Device Name SOOTHE-N-SEAL CANKER SORE RELIEF
Applicant
Closure Medical Corp.
5250 Greens Dairy Rd.
Raleigh,  NC  27616
Applicant Contact W. THOMAS STEPHENS
Correspondent
Closure Medical Corp.
5250 Greens Dairy Rd.
Raleigh,  NC  27616
Correspondent Contact W. THOMAS STEPHENS
Regulation Number872.3275
Classification Product Code
MZW  
Date Received06/07/1999
Decision Date 09/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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