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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Table, Mechanical
510(k) Number K896256
Device Name REFLUX BED
Applicant
Cozcon, Inc.
108 Norwich Ave.
P.O. Box 142
Colchester,  CT  06415
Applicant Contact DEAN CONRAD
Correspondent
Cozcon, Inc.
108 Norwich Ave.
P.O. Box 142
Colchester,  CT  06415
Correspondent Contact DEAN CONRAD
Regulation Number890.3750
Classification Product Code
INW  
Date Received10/31/1989
Decision Date 11/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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