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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stretcher, Hand-Carried
510(k) Number K922816
Device Name U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER
Applicant
UP CUSTOM DESIGN, INC.
P.O. BOX 734
MENOMINEE,  MI  49859
Applicant Contact MICHAEL SETTERSTEN
Correspondent
UP CUSTOM DESIGN, INC.
P.O. BOX 734
MENOMINEE,  MI  49859
Correspondent Contact MICHAEL SETTERSTEN
Regulation Number880.6900
Classification Product Code
FPP  
Date Received06/11/1992
Decision Date 07/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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