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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transport, Patient, Powered
510(k) Number K091858
Device Name PINNACLE STAIR WAY LIFT
Applicant
Summit Harmar, LLC
5905 Fawn Ln.
Cleveland,  OH  44144
Applicant Contact EDWARD KROL
Correspondent
Summit Harmar, LLC
5905 Fawn Ln.
Cleveland,  OH  44144
Correspondent Contact EDWARD KROL
Regulation Number890.5150
Classification Product Code
ILK  
Date Received06/23/2009
Decision Date 07/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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