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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K913545
Device Name PIN DOT FLIP-DOWN ABDUCTOR
Applicant
Pin Dot Products, Inc.
6001 Gross Pt. Rd.
Niles,  IL  60648
Correspondent
Pin Dot Products, Inc.
6001 Gross Pt. Rd.
Niles,  IL  60648
Regulation Number890.3920
Classification Product Code
KNN  
Date Received08/09/1991
Decision Date 09/05/1991
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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