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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sling, Overhead Suspension, Wheelchair
510(k) Number K884787
Device Name ACCULITE-PPL 5
Applicant
Medical Alignment Systems
9160 S. 300 W., Bldg. 1,
Ste19
Sandy,  UT  84070
Applicant Contact DEBORAH S STOUT
Correspondent
Medical Alignment Systems
9160 S. 300 W., Bldg. 1,
Ste19
Sandy,  UT  84070
Correspondent Contact DEBORAH S STOUT
Regulation Number890.3910
Classification Product Code
INE  
Date Received11/15/1988
Decision Date 01/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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