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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K082553
Device Name REXASTOM ORAL EASE
Applicant
Rexaderm, Inc.
3156 Doolittle Dr.
Northbrook,  IL  60062
Applicant Contact CLYDE R GOODHEART
Correspondent
Rexaderm, Inc.
3156 Doolittle Dr.
Northbrook,  IL  60062
Correspondent Contact CLYDE R GOODHEART
Classification Product Code
OLR  
Date Received09/03/2008
Decision Date 11/21/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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