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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 K020495
Device Name INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
Applicant
Surgi-Vision, Inc.
20 Firstfield Rd. Suite 200
Gaithersburg,  MD  20878
Applicant Contact NANCY E TAYLOR
Correspondent
Surgi-Vision, Inc.
20 Firstfield Rd. Suite 200
Gaithersburg,  MD  20878
Correspondent Contact NANCY E TAYLOR
Regulation Number892.1000
Classification Product Code
MOS  
Date Received02/14/2002
Decision Date 04/23/2002
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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