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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 K895444
Device Name THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION
Applicant
Mcvicar Enterprises, Ltd.
461 Linden Pl., B.C. Vor
2t0, Box 878
Qualicum Beach,  CA
Applicant Contact DIARMID MCVICAR
Correspondent
Mcvicar Enterprises, Ltd.
461 Linden Pl., B.C. Vor
2t0, Box 878
Qualicum Beach,  CA
Correspondent Contact DIARMID MCVICAR
Regulation Number890.3750
Classification Product Code
INW  
Date Received09/05/1989
Decision Date 12/13/1989
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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