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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K860068
Device Name FOOT PEDAL COVER
Applicant
O.R. Concepts, Inc.
1328 Shady Springs Ct.
Irving,  TX  75060
Applicant Contact STALEY, JR.
Correspondent
O.R. Concepts, Inc.
1328 Shady Springs Ct.
Irving,  TX  75060
Correspondent Contact STALEY, JR.
Date Received01/06/1986
Decision Date 01/27/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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