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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 K952419
Device Name STERIGAUZE GEL DRESSING
Applicant
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Applicant Contact BEN WALTHALL
Correspondent
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Correspondent Contact BEN WALTHALL
Classification Product Code
MGQ  
Date Received05/23/1995
Decision Date 07/26/1995
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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