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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer, ent synthetic-polyamide (mesh or foil material)
510(k) Number K003855
Device Name HYALOMATRIX CO
Applicant
FIDIA ADVANCED BIOPOLYMERS SRL
VIA PONTE DELLA FABBRICA,3/A
35031 ABANO TERME (PD),  IT 35031
Applicant Contact PAOLO RAMPAZZO
Correspondent
FIDIA ADVANCED BIOPOLYMERS SRL
VIA PONTE DELLA FABBRICA,3/A
35031 ABANO TERME (PD),  IT 35031
Correspondent Contact PAOLO RAMPAZZO
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received12/13/2000
Decision Date 07/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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