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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K994339
Device Name HYCURE ORAL / HYCURE ORAL SMART GEL
Applicant
The Hymed Group Corp.
1890 Bucknell Dr.
Bethlehem,  PA  18015
Applicant Contact ANITA M PETITO
Correspondent
The Hymed Group Corp.
1890 Bucknell Dr.
Bethlehem,  PA  18015
Correspondent Contact ANITA M PETITO
Classification Product Code
KGN  
Date Received12/23/1999
Decision Date 03/22/2000
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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