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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K935203
Device Name WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
Applicant
Renaissance Medical, Inc.
33971 Selva
Suite 100
Dana Point,  CA  92629
Applicant Contact DARLENE TAYLOR-MCCORD
Correspondent
Renaissance Medical, Inc.
33971 Selva
Suite 100
Dana Point,  CA  92629
Correspondent Contact DARLENE TAYLOR-MCCORD
Classification Product Code
MGQ  
Date Received10/26/1993
Decision Date 01/18/1994
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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