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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Lift, Patient, Non-Ac-Powered
510(k) Number K902141
Device Name ANOLIFT - PORTABLE & ANOLIFT - GANTRY
Applicant
Anodyne Corp.
4023 S. U.S. 23, Suite #106
Brighton,  MI  48116
Applicant Contact DONALD D MERRY
Correspondent
Anodyne Corp.
4023 S. U.S. 23, Suite #106
Brighton,  MI  48116
Correspondent Contact DONALD D MERRY
Regulation Number880.5510
Classification Product Code
FSA  
Date Received05/15/1990
Decision Date 09/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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