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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 K010583
Device Name AMBU GEL, HYDROGEL BURN DRESSING
Applicant
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090
Applicant Contact SANJAY PARIKH
Correspondent
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090
Correspondent Contact SANJAY PARIKH
Classification Product Code
MGQ  
Date Received02/27/2001
Decision Date 05/25/2001
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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