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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K002916
Device Name SURGI-VISION PROSTATE COIL
Applicant
SURGI-VISION, INC.
9250 RUMSEY RD., SUITE 100
COLUMBIA,  MD  21045
Applicant Contact NANCY E TAYLOR
Correspondent
SURGI-VISION, INC.
9250 RUMSEY RD., SUITE 100
COLUMBIA,  MD  21045
Correspondent Contact NANCY E TAYLOR
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/19/2000
Decision Date 11/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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