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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 K073251
Device Name HYALOMATRIX PA
Applicant
FIDIA ADVANCED BIOPOLYMERS SRL
1111 PENNSYLVANIA AVE NW
WASHINGTON,  DC  20004
Applicant Contact SHARON A SEGAL
Correspondent
FIDIA ADVANCED BIOPOLYMERS SRL
1111 PENNSYLVANIA AVE NW
WASHINGTON,  DC  20004
Correspondent Contact SHARON A SEGAL
Classification Product Code
FRO  
Date Received11/19/2007
Decision Date 12/14/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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