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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K092734
Device Name E-LIGHT LINE
Applicant
ESPANSIONE MARKETING S.P.A
VIA BORGO SANTA CRISTINA, 12
IMOLA, BOLOGNA,  IT 40026
Applicant Contact GUIDO BONAPACE
Correspondent
ESPANSIONE MARKETING S.P.A
VIA BORGO SANTA CRISTINA, 12
IMOLA, BOLOGNA,  IT 40026
Correspondent Contact GUIDO BONAPACE
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ISA   OAP  
Date Received09/04/2009
Decision Date 09/20/2010
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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