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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K921891
Device Name SILENT SCAN
Applicant
AVOTEC, INC.
P.O. BOX 1777
JENSEN BEACH,  FL  34958
Applicant Contact PAUL E BULLWINKEL
Correspondent
AVOTEC, INC.
P.O. BOX 1777
JENSEN BEACH,  FL  34958
Correspondent Contact PAUL E BULLWINKEL
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/22/1992
Decision Date 05/13/1993
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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