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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 K994436
Device Name SURGI-VISION ESOPHAGEAL STYLET 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 Received12/30/1999
Decision Date 03/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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