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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 K130959
Device Name AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL
Applicant
Bioplax Limited
472 S State St., #101
Bellingham,  WA  98225
Applicant Contact PAUL KETTERIDGE
Correspondent
Bioplax Limited
472 S State St., #101
Bellingham,  WA  98225
Correspondent Contact PAUL KETTERIDGE
Classification Product Code
OLR  
Date Received04/05/2013
Decision Date 04/04/2014
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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