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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 K961766
Device Name WOUND HYDROGEL & STERILE WOUND HYDROGEL
Applicant
Renaissance Pharmaceutical, Inc.
P.O. Box 216
Glenbrook,  NV  89413
Applicant Contact DARLENE TAYLOR-MCCORD
Correspondent
Renaissance Pharmaceutical, Inc.
P.O. Box 216
Glenbrook,  NV  89413
Correspondent Contact DARLENE TAYLOR-MCCORD
Classification Product Code
MGQ  
Date Received05/03/1996
Decision Date 07/15/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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