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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Transfer, Patient, Manual
510(k) Number K801796
Device Name THE COMFORT LIFT
Applicant
Gettner Enterprises, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gettner Enterprises, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6785
Classification Product Code
FMR  
Date Received07/29/1980
Decision Date 08/13/1980
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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