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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K042084
Device Name BIODERM SCIENCES WOUND HEALING SPRAY
Applicant
Bioderm Sciences, Inc.
101 Orchard Ridge Dr.
Suite 1n
Gaithersburg,  MD  20878
Applicant Contact EDWARD R GUBISH
Correspondent
Bioderm Sciences, Inc.
101 Orchard Ridge Dr.
Suite 1n
Gaithersburg,  MD  20878
Correspondent Contact EDWARD R GUBISH
Classification Product Code
FRO  
Date Received08/03/2004
Decision Date 06/15/2005
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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