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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 K122358
Device Name NOVEON
Applicant
HOGAN LOVELLS US, L.L.P.
1835 MARKET STREET
29TH FLOOR
PHILIDELPHIA,  PA  19103
Applicant Contact JANICE HOGAN
Correspondent
HOGAN LOVELLS US, L.L.P.
1835 MARKET STREET
29TH FLOOR
PHILIDELPHIA,  PA  19103
Correspondent Contact JANICE HOGAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/03/2012
Decision Date 03/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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