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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K874246
Device Name IRON HORSE ONE
Applicant
Iron Horse Productions, Inc.
2624 Conner St.
Port Huron,  MI  48060
Applicant Contact DUFFY, JR.
Correspondent
Iron Horse Productions, Inc.
2624 Conner St.
Port Huron,  MI  48060
Correspondent Contact DUFFY, JR.
Regulation Number890.3850
Classification Product Code
IOR  
Date Received10/16/1987
Decision Date 11/23/1987
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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