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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K040584
Device Name NMX-1000
Applicant
NEOMEDIX CORP.
27452 CALLE ARROYO
san juan capistrano,  CA  92675 -2748
Applicant Contact soheila mirhashemi
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
camas,  WA  98607 -9526
Correspondent Contact marc mouser
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HQR  
Date Received03/05/2004
Decision Date 04/22/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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