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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K070961
FOIA Releasable 510(k) K070961
Device Name BIOMERIX SURGICAL MESH, MODEL: RCR-01
Applicant
BIOMERIX CORPORATION
1700 ROCKVILLE PIKE
SUITE 400
ROCKVILLE,  MD  20852
Applicant Contact CHRISTINA L KICHULA
Correspondent
BIOMERIX CORPORATION
1700 ROCKVILLE PIKE
SUITE 400
ROCKVILLE,  MD  20852
Correspondent Contact CHRISTINA L KICHULA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/05/2007
Decision Date 02/25/2008
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
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