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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 K030235
Device Name F1 DIODE LASER SYSTEM
Applicant
OPUS MEDICAL, INC.
1684 EAST GUDE DR.
SUITE 202
ROCKVILLE,  MD  20850
Applicant Contact RENE VAN DE ZANDE
Correspondent
OPUS MEDICAL, INC.
1684 EAST GUDE DR.
SUITE 202
ROCKVILLE,  MD  20850
Correspondent Contact RENE VAN DE ZANDE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/23/2003
Decision Date 04/23/2003
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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