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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 And Burn, Occlusive
510(k) Number K001508
Device Name LASERSKIN DRESSING
Applicant
Fidia Advanced Biopolymers Srl
Via Ponte Della Fabbrica 3/A
Abano Terme,  IT 35031
Applicant Contact PAOLO RAMPAZZO
Correspondent
Fidia Advanced Biopolymers Srl
Via Ponte Della Fabbrica 3/A
Abano Terme,  IT 35031
Correspondent Contact PAOLO RAMPAZZO
Classification Product Code
MGP  
Date Received05/15/2000
Decision Date 07/25/2001
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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