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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K860066
Device Name REFLECTIVE BLANKET
Applicant
O.R. Concepts, Inc.
1328 Shady Springs Court
Irving,  TX  75060
Applicant Contact STALEY, JR.
Correspondent
O.R. Concepts, Inc.
1328 Shady Springs Court
Irving,  TX  75060
Correspondent Contact STALEY, JR.
Regulation Number880.6060
Classification Product Code
KME  
Date Received01/06/1986
Decision Date 02/19/1986
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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