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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 K982761
Device Name JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031
Applicant
CHAMCO, INC.
798 CLEARLAKE RD.
COCOA,  FL  32922
Applicant Contact JIM CUMMINS
Correspondent
CHAMCO, INC.
798 CLEARLAKE RD.
COCOA,  FL  32922
Correspondent Contact JIM CUMMINS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/06/1998
Decision Date 10/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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