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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 K080471
Device Name RADIO BIOAQUACARE
Applicant
Bioartificial Gel Technologies (Bagtech), Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
Bioartificial Gel Technologies (Bagtech), Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JONATHAN KAHAN
Classification Product Code
FRO  
Date Received02/21/2008
Decision Date 03/05/2008
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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