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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Expander, Surgical, Skin Graft
510(k) Number K080158
Device Name LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
Applicant
Lb Medical LLC
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact TERRY SHERIDAN POWELL
Correspondent
Lb Medical LLC
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact TERRY SHERIDAN POWELL
Regulation Number878.4800
Classification Product Code
FZW  
Date Received01/23/2008
Decision Date 05/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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