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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K843572
Device Name PDB II VIBRATING DRAINAGE BED
Applicant
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036
Applicant Contact JAMES A GERBER
Correspondent
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036
Correspondent Contact JAMES A GERBER
Regulation Number890.5880
Classification Product Code
JFB  
Date Received09/11/1984
Decision Date 11/23/1984
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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